Changes In Blood Components In Patients With Ovarian Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-005263
Sponsor Protocol Number: 12-005263
About this study
The purpose of this study is to assemble a collection of serial plasma biospecimens from women with ovarian, primary peritoneal, or fallopian tube cancer for future research projects to identify changes in levels of various plasma components that occur during the course of ovarian cancer, including changes that occur with debulking surgery, chemotherapy, disease relapse, and subsequent therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Both Aims
- Women with a pathologic diagnosis of OC.
- Able to provide informed consent.
Aim 1 and 1a:
- Underwent debulking surgery for OC within the past 42 days, or planning to receive neoadjuvant chemotherapy or chemotherapy only.
Aim 2:
- Received at least one prior systemic chemotherapy regimen for OC.
- Developed recurrence or progression of OC during or after at least one course of systemic chemotherapy.
- Planning to receive additional systemic therapy for OC. (Patients not planning to receive additional therapy at Mayo Clinic Rochester must be enrolled in IRB protocol 08-005749.)
Exclusion Criteria:
Both Aims:
- Borderline tumor or non-epithelial histology (germ cell tumor, carcinosarcoma, etc.).
- Other malignancy within the past five years, other than non-melanoma skin cancers that have been completely resected or cervical carcinoma in situ.
Aim 1 and 1a:
- Already received systemic chemotherapy for OC prior to study entry. (While the goal is to enroll patients before their first dose of chemotherapy, patients who have received at most three cycles of their first course of chemotherapy may participate.)
Aim 2
- Receipt of vaccines or immunotherapy for OC.Aim 2:
- Receipt of systemic anti-cancer therapy within 14 days before study blood draw.
- Current (within the past 7 days) known or suspected infection.
- Absolute neutrophil count (ANC) < 1000
- Platelet count < 75,000.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Scott Kaufmann, M.D., Ph.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available