Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00897039|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 12, 2009
Last Update Posted : September 20, 2013
RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment.
PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
|Condition or disease||Intervention/treatment|
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Other: flow cytometry Other: immunohistochemistry staining method|
- Evaluate the ability of the microculture kinetic (MiCK) assay to predict the outcome of patients with ovarian, fallopian tube, or primary peritoneal adenocarcinoma treated with first-line chemotherapy.
- Evaluate the ability of the MiCK assay to guide chemotherapy in a third-line, refractory treatment setting (exclusive of anti-vascular endothelial growth factor) in these patients.
OUTLINE: Patients are stratified according to prior chemotherapy (no [stratum I] vs yes [stratum II]).
Tumor tissue and/or effusion specimens are collected at baseline. Specimens are examined by the microculture kinetic (MiCK) assay and immunocytochemical or flow cytometry assay.
MiCK assay results do not influence treatment for stratum I patients. Stratum II patients may receive treatment based on MiCK assay results for tumor sensitivity to specific chemotherapy drugs.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Application of the Microculture Kinetic (MiCK) Assay for Apoptosis to Testing Drug Sensitivity of Ovarian, Fallopian and Primary Peritoneal Adenocarcinomas|
|Study Start Date :||March 2006|
- Correlation of a statistically significant discriminator of sensitivity with complete response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897039
|United States, Georgia|
|Southeastern Gynecologic Oncology, LLP - Northside||Recruiting|
|Atlanta, Georgia, United States, 30342|
|Contact: Clinical Trials Office - Southeastern Gynecologic Oncology, LL 678-420-4154|
|Study Chair:||Vladimir D. Kravtsov, MD||Pierian Biosciences|
|OverallOfficial:||Matthew O. Burrell, MD||Southeastern Gynecologic Oncology|