Scco_medicalhistoryform

Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Barcode will be completed by TGen
Form Completed By
SCCO Patient
Family Member (please specify relationship)
______________________________


At date of completion of this form, patient is:  Alive  Deceased  date of death _____/_____/_____
1. Symptoms prior to diagnosis of SCCO

1a. First diagnosed with Small Cell Carcinoma of the Ovary (SCCO)
Date of diagnosis _____/______/_________
1b. Describe the physical symptoms experienced prior to diagnosis of SCCO (check all the apply)
 Urinary symptoms (increased urgency and frequency)  Difficulty with eating or feeling full quickly  Pressure or pain in the back or legs  Other. Explain: _____________________________________________________________________  Other. Explain: _____________________________________________________________________  Other. Explain: _____________________________________________________________________ 1c. How long did patient experience some or all of these symptoms before diagnosis? ____ yrs____ months 2. Patient History of Cancer

2a. Was there a diagnosis and treatment for any other type of cancer before diagnosis of SCCO?
 complete below: (Check here  and use reverse for more space.) Type: _______________________ Date: ______/_____/_________ Details: _______________________________________________________________________________ Type: _______________________ Date: ______/_____/_________ Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Details: _______________________________________________________________________________ Comments: _______________________________________________________________________________ _________________________________________________________________________________________ 2b. Was a genetic test performed to determine whether patient had an abnormality in either the BRCA1 gene or  Check here  if BRCA1 mutation test was positive  Check here  if BRCA2 mutation test was positive 2c. Were other genetic or DNA tests performed to evaluate possible genetic alterations for this patient?  Explain: (Check here  and use reverse for more space.)_______________________ __________________________________________________________________________________
3. Patient Family History of Cancer (First-Degree Relatives)

3. Do any of the patient’s first-degree relatives, for example, parents, siblings, or children have a history of If yes, complete all below. (Check here  and use reverse for more space.) Relative 1: _______________ Cancer type: ___________________ Age at Diagnosis if known: _____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Relative 2: ______________ Cancer type: ___________________ Age at Diagnosis if known: _____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Relative 3: _______________ Cancer type: ___________________ Age at Diagnosis if known: _____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Check here  if additional first-degree relatives have a history of cancer and use reverse. Continued on next page. 4. Patient Family History of Cancer (Second-Degree Relatives)
Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Barcode will be completed by TGen 4. Do any of the patient’s second-degree relatives, for example, grandparents, aunts, uncles, or cousins, have a If yes, complete below: (Check here  and use reverse for more space.)  Paternal Cancer type: ______________ Age at Diagnosis if known: ____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Relative 2: ______________  Paternal Cancer type: ______________ Age at Diagnosis if known: ____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Relative 3: ______________  Paternal Cancer type: _______________ Age at Diagnosis if known: ____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Relative 4: ______________  Paternal Cancer type: _______________ Age at Diagnosis if known: ____ Details: _______________________________________________________________________________ _____________________________________________________________________________________ Check here  if additional second-degree relatives have a history of cancer and use reverse. 5. Risk Factors - Hormonal

5a. What was the patient’s age at her first period (Menarche)?  Unknown  Go to question 5c  How many children did patient give birth to?  How many miscarriages or abortions did patient have? ________ 5c. What was patient’s menopausal status at time of diagnosis of SCCO:  Unknown  Unsure Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Menstruation not yet started. No menopausal symptoms. Going through menopause* (see below for common symptoms) Menopausal symptoms have finished. *Common symptoms of going through menopause (the beginning of menopausal symptoms typically occur in women ages 45-55 but some women show symptoms in their 30s. • Changes in pattern of periods (can be shorter or longer, lighter or heavier, more or less time between periods) • Hot flashes (sudden rush of heat in upper body) • Night sweats (hot flashes that happen while you sleep), often followed by a chill • Trouble sleeping through the night (with or without night sweats) • Mood changes. Irritability. Trouble focusing, feeling mixed-up or confused, • Hair loss or thinning on your head. More hair growth on your face 5d. Did patient use contraceptives for birth control at any time?  Did patient use hormonal contraceptives?  Does patient currently use hormonal contraceptives?  Did patient stop using hormonal contraceptives 10 or 5e. List any names or types and duration of contraceptives you recall were used by patient: Currently Use Total Use in Years or Months ____ Years ____ Months  Unknown ____ Years ____ Months  Unknown ____ Years ____ Months  Unknown If known, names: _______________________________________________________________________
6. Risk Factors – Lifestyle

6a. Did patient gain weight since turning 18 years of age and before diagnosis of SCCO?
 Unknown  Go to question 6b  What was the amount of weight gain (in pounds)? 6b. At the time of diagnosis, did patient smoke? Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
 Unknown  Go to question 6c  Did patient smoke at any time previously?  Yes  How long ago did patient quit? ___ Months or ___ Years  Unknown  How long did patient smoke for? ___ Months or ___ Years  Unknown 6c. At the time of diagnosis, did patient drink alcohol?  Average number of drinks: _____ per  Day 7. Risk Factors – Other

7a. Did patient at any time have a diagnosis of one of the following? (check all that apply).
 Kaposi's sarcoma-associated herpesvirus (KSHV) 7b. List all possible vaccinations you can recall for this patient and approximate year if known. Vaccine: _________________________ year _______ Vaccine: _________________________ year _______ Vaccine: _________________________ year _______ Vaccine: _________________________ year _______ Check here  and list additional vaccine information on reverse. 7b. Are there any unusual environmental exposures for the patient you would like to include? For example, exposure to nuclear fallout or significant levels of radiation, work with toxic/carcinogenic substances, exposure to unusual pathogens, etc. Describe: _____________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ ______________________________________________________________________________________ Check here  if additional details on environmental exposures and use reverse. Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Barcode will be completed by TGen
8. Treatment
8a. Did patient have surgery to remove the ovarian cancer?
 No  Did patient receive chemotherapy or any other treatments to shrink the cancer?  Yes  Date of Surgery (MM/DD/YYYY): ______/______/_______  Name of Doctor: __________________________________________  Hospital or clinic name: ____________________________________  Is a copy of the pathology report available?  Is a copy of the cytology report available? Note: TGen will require a de-identified copy of the patient’s final pathology report(s) and cytology report (if cytology was requested by the surgeon). Patient personal identifying information can either be blanked out by you, or the TGen Research Coordinator will do this for you before it reaches the Researchers for this study. 8b. What chemotherapy did patient receive? (check all that apply):  Cisplatin (cisplatinum, or cis-diamminedichloroplatinum(II) or CDDP)  Cyclophosphamide (Endoxan, Cytoxan, Neosar, Procytox, Revimmune)  Doxorubicin (Adriamycin, hydroxydaunorubicin).  Etoposide (Eposin, Etopophos, Vepesid, VP-1)  Other________________________________  Other________________________________ Additional details: (Check here  and use reverse for more space.)______________________________ Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Barcode will be completed by TGen 8c. Was there a diagnosis of ‘hypercalcemia’? Hypercalcemia is a high level of calcium in the blood. If yes, did hypercalcemia symptoms (typically nausea and / or vomiting) lessen or disappear following 8d. Is (or was) patient receiving any other kind of treatment other than surgery and chemotherapy (like radiation)?  Unsure  Go to question 8e  Yes  Please explain, including dates of treatment: (Check here  and use reverse for more space.) ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ 8e. Is (or was) patient receiving any other prescribed medications as part of her care?  complete below. (Check here  and use reverse for more space.) Comments: _______________________________________________________________________________ _________________________________________________________________________________________ Protocol: hcunliffe10-032
PRIVILEGED COMMUNICATION FOR INVESTIGATIONAL USE ONLY MEDICAL HISTORY FORM
Barcode will be completed by TGen 8f. Is (or was) patient diagnosed with any other medical conditions or co-morbidities? (examples listed below) Connective tissue disease Diabetes type 1 or type 2 Diabetes with end organ damage type 1 or type 2 Lymphoma Moderate or severe liver disease Any tumor (not ovarian cancer)  Yes  complete below. (Check here  and use reverse for more space.)  No  Unknown  NA Comments: _______________________________________________________________________________ _________________________________________________________________________________________
Data Collection Form Receiving - To be completed by TGen staff:

Copy received at TGen by: _________________________________________ Date: ______/______/______
Comments: _______________________________________________________________________________

Source: http://public.tgen.org/tgen.org/scco/SCCO_medical_history_form.pdf