Principle Investigator(s): Lee Shulman, MD & Shohreh Shahabi, MD
Manager: Kisha Hope kisha.hope@northwestern.edu
IRB Protocol Name: NU 99G8: Northwestern Ovarian Cancer Early Detection and Prevention Program: A Specimen and Data Study
IRB Protocol Number: STU00005421
Description:
The aim of the Northwestern Ovarian Cancer Early Detection & Prevention Program (NOCEDPP): A Specimen and Data Study is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists. This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.
IRB Process: IRB approval or exemption must be obtained prior to release of data or specimens. The request form will ask you input your IRB number or declare your IRB exemption.
Scientific Justification: The request form will ask you to attach a 'Methods/Justifications' document that should contain a scientific explanation justifying the disbursement of the clinical data and/or clinical specimens.
Sample Type |
Patients |
Total Samples |
Whole Blood |
776 |
2166 |
Plasma |
1191 |
12452 |
Serum |
1192 |
10911 |
Frozen Tissue |
8 |
42 |
Urine |
9 |
75 |
TOTAL |
|
25646 |
This is a general descripiton of the clinical data pionts collected for the clinical research repository. Provide high level counts broken down by demographics:
Race | Female |
---|---|
White | 997 |
Black | 37 |
Native Hawaiian or Other Pacific Islander | 2 |
Asian | 20 |
American Indian or Alaska Native | 3 |
Unknown | 34 |
Cohort - Samples |
Patients with Samples |
Ovarian Cancer Dx |
18 |
Breast Cancer Dx |
279 |
Fallopian Cancer Dx |
4 |
Uterine Cancer Dx |
5 |
Unaffected (No Cancer) |
803 |
BRCA 1/2 + |
152 |
BRCA 1/2 - |
263 |
BRCA Mutation Carriers |
249
|
||||||
Lynch Mutation Carriers |
12
|
The broad categories of the clinical data points collected within the NOCEDPP are the following