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DNA Methylation as a Predictor for Response and Progression-Free Survival in Patients With Ovarian Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

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Trial Information

DNA Methylation as a Predictor for Response and Progression-Free Survival in Patients With Ovarian Cancer


OBJECTIVES:

- To determine if DNA methylation patterns and expression of differentially methylated
genes taken before chemotherapy can predict patient outcome with regard to
progression-free survival.

- To evaluate whether DNA methylation can predict response assessed by RECIST criteria
and CA 125 response.

- To evaluate the specificity and sensitivity of predicting methylation changes in tumor
from the changes at the corresponding CpG islands in plasma.

OUTLINE: Tumor samples are collected at the time of initial laparotomy and blood is drawn
prior to surgery for DNA methylation and biomarker studies.

Changes in DNA methylation will be examined globally using DNA methylation hybridization to
microarrays and methylation specific PCR, as well as expression of genes shown to be
differentially methylated.

Inclusion Criteria


1. Clinically suspected FIGO stages Ic-IV epithelial ovarian cancer that are about to
undergo surgery for confirmatory biopsy and attempted cytoreductive surgery

2. Given written informed consent

3. Female and >18 years of age

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Progression-free survival

Outcome Description:

To determine if DNA methylation patterns and expression differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.

Outcome Time Frame:

Ongoing

Safety Issue:

No

Principal Investigator

Nadeem Siddiqui, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottish Gynaecological Cancer Trials Group

Authority:

United Kingdom: Research Ethics Committee

Study ID:

CDR0000577616

NCT ID:

NCT00900289

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage IC ovarian epithelial cancer
  • stage IIA ovarian epithelial cancer
  • stage IIB ovarian epithelial cancer
  • stage IIC ovarian epithelial cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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