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SCCO Medical History Form

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Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

<strong>Form</strong> Completed By<br />

<strong>SCCO</strong> Patient<br />

Family Member (please specify relationship)<br />

______________________________<br />

Date Completed: _____/______/_________<br />

MM DD YYYY<br />

At date of completion of this form, patient is: Alive Deceased date of death _____/_____/_____<br />

MM DD YYYY<br />

1. Symptoms prior to diagnosis of <strong>SCCO</strong><br />

1a. First diagnosed with Small Cell Carcinoma of the Ovary (<strong>SCCO</strong>)<br />

Date of diagnosis _____/______/_________ Patient Age at Diagnosis _________<br />

MM DD YYYY<br />

1b. Describe the physical symptoms experienced prior to diagnosis of <strong>SCCO</strong> (check all the apply)<br />

A swollen or bloated abdomen<br />

Pressure or pain in the abdomen<br />

Pressure or pain in pelvis<br />

Pressure or pain in the back or legs<br />

Shortness of breath<br />

Excessive fatigue<br />

Unusual vaginal bleeding<br />

Urinary symptoms (increased urgency and frequency)<br />

Difficulty with eating or feeling full quickly<br />

Nausea<br />

Vomiting<br />

Gas<br />

Constipation<br />

Indigestion<br />

Other. Explain: _____________________________________________________________________<br />

Other. Explain: _____________________________________________________________________<br />

Other. Explain: _____________________________________________________________________<br />

1c. How long did patient experience some or all of these symptoms before diagnosis ____ yrs____ months<br />

2. Patient <strong>History</strong> of Cancer<br />

2a. Was there a diagnosis and treatment for any other type of cancer before diagnosis of <strong>SCCO</strong><br />

No Go to question 2b<br />

Unsure Go to question 2b<br />

Yes complete below: (Check here and use reverse for more space.)<br />

Type: _______________________ Date: ______/_____/_________<br />

MM DD YYYY<br />

Details: _______________________________________________________________________________<br />

continued on next page<br />

Type: _______________________ Date: ______/_____/_________<br />

MM DD YYYY<br />

© TGen BOCRU 2006 Page 1 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

Details: _______________________________________________________________________________<br />

Comments: _______________________________________________________________________________<br />

_________________________________________________________________________________________<br />

2b. Was a genetic test performed to determine whether patient had an abnormality in either the BRCA1 gene or<br />

the BRCA2 gene<br />

No Go to question 2c<br />

Unknown Go to question 2c<br />

Yes Check here if BRCA1 mutation test was positive<br />

Check here if BRCA2 mutation test was positive<br />

2c. Were other genetic or DNA tests performed to evaluate possible genetic alterations for this patient<br />

No Go to question 3<br />

Unknown Go to question 3<br />

Yes Explain: (Check here and use reverse for more space.)_______________________<br />

__________________________________________________________________________________<br />

3. Patient Family <strong>History</strong> of Cancer (First-Degree Relatives)<br />

3. Do any of the patient’s first-degree relatives, for example, parents, siblings, or children have a history of<br />

cancer of any kind Yes No Unknown<br />

If yes, complete all below.<br />

(Check here and use reverse for more space.)<br />

Relative 1: _______________ Cancer type: ___________________ Age at Diagnosis if known: _____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Relative 2: ______________ Cancer type: ___________________ Age at Diagnosis if known: _____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Relative 3: _______________ Cancer type: ___________________ Age at Diagnosis if known: _____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Check here if additional first-degree relatives have a history of cancer and use reverse. Continued on next page.<br />

4. Patient Family <strong>History</strong> of Cancer (Second-Degree Relatives)<br />

© TGen BOCRU 2006 Page 2 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

4. Do any of the patient’s second-degree relatives, for example, grandparents, aunts, uncles, or cousins, have a<br />

history of cancer Yes No Unknown<br />

If yes, complete below: (Check here and use reverse for more space.)<br />

Relative 1: ____________<br />

Maternal<br />

Paternal Cancer type: ______________ Age at Diagnosis if known: ____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Maternal<br />

Relative 2: ______________ Paternal Cancer type: ______________ Age at Diagnosis if known: ____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Maternal<br />

Relative 3: ______________ Paternal Cancer type: _______________ Age at Diagnosis if known: ____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Maternal<br />

Relative 4: ______________ Paternal Cancer type: _______________ Age at Diagnosis if known: ____<br />

Details: _______________________________________________________________________________<br />

_____________________________________________________________________________________<br />

Check here if additional second-degree relatives have a history of cancer and use reverse.<br />

5. Risk Factors - Hormonal<br />

5a. What was the patient’s age at her first period (Menarche) ________ Unknown<br />

5b. Was patient pregnant at any time<br />

No Go to question 5c<br />

Unknown Go to question 5c<br />

Yes How many pregnancies ________ Unknown<br />

Patient age at first pregnancy ________ Unknown<br />

How many children did patient give birth to ________ Unknown<br />

How many miscarriages or abortions did patient have ________ Unknown<br />

continued on next page<br />

5c. What was patient’s menopausal status at time of diagnosis of <strong>SCCO</strong>: Unknown Unsure<br />

© TGen BOCRU 2006 Page 3 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

Pre-pubescent<br />

Pre-menopausal<br />

Peri-menopausal<br />

Post-menopausal<br />

Menstruation not yet started. No menopausal symptoms.<br />

No menopausal symptoms<br />

Going through menopause* (see below for common symptoms)<br />

Menopausal symptoms have finished.<br />

*Common symptoms of going through menopause (the beginning of menopausal symptoms typically occur in women ages<br />

45-55 but some women show symptoms in their 30s.<br />

• Changes in pattern of periods (can be shorter or longer, lighter or heavier, more or less time between periods)<br />

• Hot flashes (sudden rush of heat in upper body)<br />

• Night sweats (hot flashes that happen while you sleep), often followed by a chill<br />

• Trouble sleeping through the night (with or without night sweats)<br />

• Mood changes. Irritability. Trouble focusing, feeling mixed-up or confused,<br />

• Hair loss or thinning on your head. More hair growth on your face<br />

• Vaginal dryness.<br />

5d. Did patient use contraceptives for birth control at any time<br />

No Go to question 6<br />

Unknown Go to question 6<br />

Yes Did patient use hormonal contraceptives Y N Unknown<br />

Does patient currently use hormonal contraceptives Y N Unknown<br />

Did patient stop using hormonal contraceptives 10 or<br />

more years ago Y N Unknown<br />

5e. List any names or types and duration of contraceptives you recall were used by patient:<br />

Type Used Previously Currently Use Total Use in Years or Months<br />

Oral (“the pill”) ____ Years ____ Months Unknown<br />

IUD (“Mirena/Progestin”) ____ Years ____ Months Unknown<br />

IUD (“Paraguard/Copper”) ____ Years ____ Months Unknown<br />

Implant (“Implanon”) ____ Years ____ Months Unknown<br />

Skin patch (“Ortho Evra”) ____ Years ____ Months Unknown<br />

Injection (“Depo-Provera”) ____ Years ____ Months Unknown<br />

Vaginal ring (“NuvaRing”) ____ Years ____ Months Unknown<br />

Other: _________________ ____ Years ____ Months Unknown<br />

If known, names: _______________________________________________________________________<br />

6. Risk Factors – Lifestyle<br />

6a. Did patient gain weight since turning 18 years of age and before diagnosis of <strong>SCCO</strong><br />

No Go to question 6b<br />

Unknown Go to question 6b<br />

Yes What was the amount of weight gain (in pounds)<br />

0-15 16-30 31-50 More than 50 Unknown<br />

continued on next page<br />

6b. At the time of diagnosis, did patient smoke<br />

© TGen BOCRU 2006 Page 4 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

Unknown Go to question 6c<br />

Yes How many packs per week ___ Unknown<br />

How long did patient smoke for ___ Months or ___ Years Unknown<br />

No<br />

Did patient smoke at any time previously<br />

No Go to question 6c.<br />

Yes How long ago did patient quit ___ Months or ___ Years Unknown<br />

How long did patient smoke for ___ Months or ___ Years Unknown<br />

How many packs per week ___ Unknown<br />

6c. At the time of diagnosis, did patient drink alcohol<br />

No Go to question 7<br />

Unknown Go to question 7<br />

Yes Average number of drinks: _____ per Day Week Unknown<br />

Month Year<br />

7. Risk Factors – Other<br />

7a. Did patient at any time have a diagnosis of one of the following (check all that apply).<br />

Human papillomavirus (HPV)<br />

Hepatitis B Virus (HBV)<br />

Hepatitis C Virus (HBV)<br />

Epsein-Barr Virus (EBV)<br />

Human T-lymphotropic Virus (HTLV) Kaposi's sarcoma-associated herpesvirus (KSHV)<br />

Merkel cell polyomavirus (MCPV) None I am aware of.<br />

7b. List all possible vaccinations you can recall for this patient and approximate year if known.<br />

Vaccine: _________________________<br />

Vaccine: _________________________<br />

Vaccine: _________________________<br />

Vaccine: _________________________<br />

year _______<br />

year _______<br />

year _______<br />

year _______<br />

Check here and list additional vaccine information on reverse.<br />

7b. Are there any unusual environmental exposures for the patient you would like to include<br />

For example, exposure to nuclear fallout or significant levels of radiation, work with toxic/carcinogenic<br />

substances, exposure to unusual pathogens, etc.<br />

Describe: _____________________________________________________________________________<br />

______________________________________________________________________________________<br />

______________________________________________________________________________________<br />

______________________________________________________________________________________<br />

Check here if additional details on environmental exposures and use reverse.<br />

continued on next page<br />

© TGen BOCRU 2006 Page 5 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

8. Treatment<br />

8a. Did patient have surgery to remove the ovarian cancer<br />

No<br />

Did patient receive chemotherapy or any other treatments to shrink the cancer<br />

No Go to Question 8e.<br />

Yes Go to Question 8c.<br />

Yes Date of Surgery (MM/DD/YYYY): ______/______/_______<br />

Name of Doctor: __________________________________________<br />

Hospital or clinic name: ____________________________________<br />

Is a copy of the pathology report available Y N<br />

Is a copy of the cytology report available Y N Report not ordered<br />

Note: TGen will require a de-identified copy of the patient’s final pathology report(s) and cytology report (if<br />

cytology was requested by the surgeon). Patient personal identifying information can either be blanked out by<br />

you, or the TGen Research Coordinator will do this for you before it reaches the Researchers for this study.<br />

8b. What chemotherapy did patient receive (check all that apply): Weeks Cycles<br />

Paclitaxel (taxane, taxol) _____ _____<br />

Cisplatin (cisplatinum, or cis-diamminedichloroplatinum(II) or CDDP) _____ _____<br />

Carboplatin _____ _____<br />

Cyclophosphamide (Endoxan, Cytoxan, Neosar, Procytox, Revimmune) _____ _____<br />

Bleomycin (Blenoxane, Bleocip) _____ _____<br />

Doxorubicin (Adriamycin, hydroxydaunorubicin). _____ _____<br />

Etoposide (Eposin, Etopophos, Vepesid, VP-1) _____ _____<br />

Vinblastine (vincristine) _____ _____<br />

Unsure _____ _____<br />

Other________________________________ _____ _____<br />

Other________________________________ _____ _____<br />

Not applicable<br />

Additional details: (Check here and use reverse for more space.)______________________________<br />

Date chemotherapy started : _____/______/_______ Unknown<br />

MM DD YYYY<br />

Date chemotherapy completed: _____/______/_______ Unknown<br />

MM DD YYYY<br />

continued on next page<br />

© TGen BOCRU 2006 Page 6 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

8c. Was there a diagnosis of ‘hypercalcemia’ Hypercalcemia is a high level of calcium in the blood.<br />

Y N Unknown<br />

If yes, did hypercalcemia symptoms (typically nausea and / or vomiting) lessen or disappear following<br />

surgery Y N Unknown<br />

Not Applicable<br />

8d. Is (or was) patient receiving any other kind of treatment other than surgery and chemotherapy (like<br />

radiation)<br />

No Go to question 8e<br />

Unsure Go to question 8e<br />

Yes Please explain, including dates of treatment: (Check here and use reverse for more space.)<br />

______________________________________________________________________________<br />

______________________________________________________________________________<br />

______________________________________________________________________________<br />

8e. Is (or was) patient receiving any other prescribed medications as part of her care<br />

Yes<br />

complete below. (Check here and use reverse for more space.)<br />

No<br />

Go to question 8f<br />

Unknown<br />

Go to question 8f<br />

Prefer not to answer Go to question 8f<br />

Drug Name Indication # months<br />

Comments: _______________________________________________________________________________<br />

_________________________________________________________________________________________<br />

continued on next page<br />

© TGen BOCRU 2006 Page 7 of 8 Version - 11/23/2010


Protocol: hcunliffe10-032<br />

PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY<br />

MEDICAL HISTORY FORM<br />

Barcode:<br />

Barcode will be completed by TGen<br />

8f. Is (or was) patient diagnosed with any other medical conditions or co-morbidities (examples listed below)<br />

Myocardial infarct Congestive heart disease Peripheral vascular disease Hemiplegia<br />

Cerebrovascular disease Chronic pulmonary disease Moderate or severe renal disease AIDS<br />

Connective tissue disease Diabetes type 1 or type 2 Diabetes with end organ damage type 1 or type 2 Lymphoma<br />

Mild liver disease Moderate or severe liver disease Any tumor (not ovarian cancer) Leukemia<br />

Ulcer disease<br />

Dementia<br />

Yes complete below. (Check here and use reverse for more space.) No Unknown NA<br />

<strong>Medical</strong> Condition<br />

Date of Diagnosis<br />

Comments: _______________________________________________________________________________<br />

_________________________________________________________________________________________<br />

Data Collection <strong>Form</strong> Receiving - To be completed by TGen staff:<br />

Copy received at TGen by: _________________________________________ Date: ______/______/______<br />

Name (Printed) MM DD YYYY<br />

Comments: _______________________________________________________________________________<br />

© TGen BOCRU 2006 Page 8 of 8 Version - 11/23/2010

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