Form:	UL Clinical v2.0

CDE ID	CDE Description
* 421	EDRN Participant ID (Go To: 423)
* 423	EDRN Protocol ID (Go To: 422)
* 422	EDRN Site ID (Go To: 929)
* 929	EDRN Staff ID of the person who collected the data: (Go To: 1219)
* 1219	Date of contact (MM/DD/YYYY): (Go To: 774)
* 2221	Ever had uterus removed? (Go To: 4882)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 4882	Has the participant had a uterine ablation procedure? (Go To: 4883)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 4883	Has the participant had a tubal ligation? (Go To: 4884)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 4884	Has the participant had a bilateral salpingectomy? (Go To: 4885)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 4885	Does the participant have a complex ovarian mass? (Go To: 4906)
	Permissible Values (value): No (0)
	Yes (1)
	Suspicious (3)
	Unknown (99)
* 4906	Does the participant have a confirmed mutation that elevates her risk of ovarian cancer? (Go To: 1645)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 4907)
	Unknown (99)
* 4907	Type of genetic mutations (check all that apply) (Go To: 1645)
	Permissible Values (value): BRACA1 (1)
	BRACA2 (2)
	Other, specify: (97) (Go To: 4908)
* 4908	Type of genetic mutations (Other, specify) (Go To: 1645)
* 1645	Prior neoadjuvant chemotherapy? (Go To: 4851)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 4851	In physician’s judgment, is the participant free from any co-morbidities that limit the participant's participation in the study? (Go To: 4909)
	Permissible Values (value): Disagree (10)
	Agree (11)
	Unknown (99)
* 4909	Is the patient undergoing risk reduction surgery (RRS)? (Go To: 4925)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 4910)
	Unknown (99)
* 4910	Type of risk reduction surgery (Go To: 4925)
	Permissible Values (value): RRS (Risk reduction surgery) (1)
	RRSO (Risk-reducing salpingo-oophorectomy) (2)
	Unknown (99)
* 4925	Has the patient undergone a tissue based (e.g. diagnostic laparoscopy) or cell-based (e.g. paracentesis) diagnostic procedure performed because of current symptoms suspicious for ovarian cancer? (Go To: 5009)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 4926)
	Unknown (99)
* 4926	Has the diagnostic procedure confirmed a diagnosis of cancer? (Go To: 5009)
	Permissible Values (value): No (0)
	Yes (1)
	Unknown (99)
* 5009	Has the participant been diagnosed with high-grade cervical dysplasia (CIN3)? (Go To: 5019)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 5010)
	Unknown (99)
* 5010	Has the participant been treated for high-grade cervical dysplasia (CIN3)? (Go To: 5019)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 5012)
	Unknown (99)
* 5012	Was there an abnormal pap smear result? (Go To: 5019)
	Permissible Values (value): No (0) (Go To: 5011)
	Yes (1)
	Unknown (99)
* 5011	Is there record of a pap smear? (Go To: 5013)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 3472)
	Unknown (99)
* 5013	Was a pap smear performed? (Go To: 5019)
	Permissible Values (value): No (0)
	Yes (1) (Go To: 3472)
	Unknown (99)
* 3472	Result of Pap test (Go To: 5019)
	Permissible Values (value): Negative for intraepithelial lesion or malignancy (1)
	Atypical squamous cells of undetermined significance (ASC-US), HPV negative (22)
	Atypical squamous cells of undetermined significance (ASC-US), HPV positive (23)
	Atypical squamous cells of undetermined significance (ASC-US), HPV unknown (24)
	Low grade SIL (including HPV changes) (3)
	Atypical squamous cells cannot exclude HSIL (ASC-H) (4)
	High grade SIL (5)
	Squamous Cell Carcinoma (including in situ) (6)
	Abnormal Glandular Cells (including Atypical, Endocervical adenocarcinoma in situ and adenocarcinoma) (7)
	Squamous Cell Carcinoma (16)
	Abnormal Glandular Cells (including Atypical, Endocervical) (17)
	Adenocarcinoma in situ (18)
	Suspicious for malignancy (19)
	Adenocarcinoma (20)
	Carcinoma, other, NOS (21)
	Specimen rejected/not processed (12)
	No result (90)
	Unknown (99)
* 5019	Is the participant taking (or has taken) any of the following immunosuppressive medications? (Check all that apply) (Go To: 4869)
	Permissible Values (value): None (0)
	Azathioprine (1)
	Corticosteroids (oral or iv) (2)
	Cyclosporine (3)
	IVIG (intravenous immunoglobulin) (4)
	Methotrexate (5)
	m-Tor inhibitor- Everolimus/ sirolimus (6)
	Rituximab (7)
	Tacrolimus (8)
	TFN-a blocker - Infliximab/etanercept/adalimumab (9)
	Refused (88)
	Unknown (99)
* 4869	Reason(s) for ovarian surgery (Check all that apply) (Go To: 1097)
	Permissible Values (value): Significantly rising CA 125 (ROCA>25%) (4)
	CA 125 > 65 IU/ml (pre-menopausal) (5)
	CA 125 > 35 IU/ml (post-menopausal) (6)
	Image abnormalities (U. Kentucky Morphology Index >=5) (7)
	Transvaginal ultrasound Kaiser-Permanente northern California (KP-NC) morphology index with high risk features, defined as either a) cyst with solid component > 1cm with vascular flow, or b) Any mass greater than 10 cm with a thick septation >3 mm or any solid component (8)
	Presence of ascites or extra-ovarian abnormalities (9)
	Investigator judgment (clinical characteristics – prob (OVCA) >25%) (10)
	Known BRCA1 mutation carrier (11)
	Known BRCA2 mutation carrier (12)
	Unknown (99)
1097	Comments (do not include any participant identifiers) (Go To: End of Form)