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Ovarian Clear Cell Adenocarcinoma Review (OCCA)

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: NCT02129036
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
National Taiwan University Hospital
Information provided by (Responsible Party):
Chih-Ming Ho, Cathay General Hospital

Tracking Information
First Submitted Date January 4, 2009
First Posted Date May 2, 2014
Last Update Posted Date August 9, 2019
Study Start Date April 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2014)
Overall survival (OS) [ Time Frame: Overall survival (up to 6 years) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02129036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ovarian Clear Cell Adenocarcinoma Review
Official Title Retrospective Multi-institutional Survey of Clinical Characteristics in Ovarian Clear Cell Adenocarcinoma Cancer Patients
Brief Summary Clear cell carcinoma comprises 5-10% of surface epithelial ovarian cancers, and about 30-40% of the patients with clear cell carcinoma are diagnosed in the advanced stage. The investigators studied the response to chemotherapy and survival for either paclitaxel-platinum based chemotherapy or conventional platinum-based chemotherapy among all stages clear cell ovarian carcinoma. Prognostic factors for survival among the patients with pure, advanced, clear cell ovarian carcinoma were also evaluated.
Detailed Description
  1. Several authors have reported frequent admixtures of clear cell ovarian carcinoma with serous, mucinous, and endometrioid tumors. However, few papers addressed the difference in response to chemotherapy and survival between patients with pure and mixed-type advanced clear cell carcinoma.
  2. Recent trends in the clinical management of advanced ovarian cancer include increased attention to maximal cytoreduction and general acceptance of paclitaxel-platinum-based adjuvant chemotherapy.
  3. The introduction of paclitaxel markedly changed the postoperative management of ovarian cancer patients, but the results and value of these newer efforts and therapies applied to clear cell carcinoma are as yet undetermined.
  4. Today, paclitaxel-platinum-based chemotherapy is becoming the standard regimen for ovarian cancer worldwide. Previous research suggests a potential benefit of paclitaxel plus carboplatin regimens for stage I clear cell carcinoma. However, few papers specifically addressed the efficacy of paclitaxel-platinum-based chemotherapy for advanced clear cell carcinoma because clear cell carcinoma occurs only rarely in Western countries.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population total 300 patients of ovarian clear cell carcinoma post operation from 8 institution.
Condition Ovarian Cysts
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2014)
5
Original Actual Enrollment Same as current
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of Ovarian clear cell carcinoma

Exclusion Criteria:

  • not undergo operation
Sex/Gender
Sexes Eligible for Study: Female
Ages 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02129036
Other Study ID Numbers TGOG-127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chih-Ming Ho, Cathay General Hospital
Study Sponsor Cathay General Hospital
Collaborators National Taiwan University Hospital
Investigators
Study Director: Chih-Ming Ho Gynecologic Cancer Center, Cathay general Hospital
PRS Account Cathay General Hospital
Verification Date April 2014