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Completed

NCT Number: NCT00628654

Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants

RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.

PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

About this study

OBJECTIVES:

Primary

  • Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.

Secondary

  • Compare the new assay to the standard CA 125 for diagnostic accuracy.

OUTLINE:

  • Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
  • Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.

PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand consent document for participation in the study
  • Not pregnant
  • Negative pregnancy test

Participants must meet 1 of the following criteria:

  • Patients scheduled for ovarian surgery for an ovarian mass
  • Healthy female volunteers with no active cancer or history of cancer

Treatment and study plan

Primary outcomes

  1. Accuracy of glycan analysis

    Time frame: one time for healthy volunteers; up to 2 years for patients with cancer

    For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).

Secondary outcomes

  1. Comparison of the new assay to the standard CA 125 assay

    Time frame: one time for healthy volunteers; up to 2 years for patients with cancer

    For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer

Important dates

Study start
2005
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2008
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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