Stage IV Ovarian Cancer Clinical Trial
Official title:
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
NCT number | NCT02441140 |
Other study ID # | 15-029 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | July 2019 |
Verified date | May 2020 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is studying a possible test which may help doctors diagnose women with ovarian cancer.
Status | Terminated |
Enrollment | 5 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Female - Age = 18 - Able to give informed consent - Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis) - Post-menopausal or negative urine and/or blood pregnancy test - Measurable disease on preoperative imaging Exclusion Criteria: - Male - Age < 18 - Unable to give informed consent - Not planned for surgical intervention - Active malignancy other than ovarian cancer - Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation) - Known or suspected active pelvic infection - Pregnancy - No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Celula, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer. | At the time of surgery | ||
Secondary | Measure the concentration of cell free DNA in various biologic fluids and compare it to primary tumor DNA. | At the time of surgery |
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