Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer

January 3, 2018 updated by: Richard G. Moore, MD, Women and Infants Hospital of Rhode Island

Development of an Assay for the Early Detection of Ovarian Cancer.

RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find cancer cells early and plan better treatment for ovarian cancer.

PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how well it works in early detection of ovarian cancer in patients with ovarian cancer or who are at risk for ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian cancer.

Secondary

  • To estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with a pelvic mass and compare LPA results from both surgical patient groups with those from "normal", disease-free women at high-risk of ovarian cancer.

Tertiary

  • To examine the response to primary adjuvant treatment and recurrence of disease.
  • To evaluate urine levels of CA125 and LPA to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass. (exploratory)

OUTLINE: Blood and urine samples are collected before or on the day of surgery; before, during, and after completing chemotherapy; or at a clinic visit. Samples are tested for concentrations of CA125 and lysophosphatidic acid (LPA) using a new assay and compared to liquid chromatography/electrospray ionization-tandem mass spectrometry results. Remaining serum, plasma, and urine is stored frozen for future research evaluation of other novel biomarkers for the diagnosis and prognosis of cancer.

After completion of study, patients are followed up periodically for approximately 5 years.

PROJECTED ACCRUAL: A total of 500 surgical patients, 100 cancer patients undergoing first-line therapy, and 40 disease-free women who are known BRCA-mutation carriers will be accrued for this study.

Study Type

Observational

Enrollment (Actual)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women presenting with a pelvic mass and scheduled to undergo surgery.

Description

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Presenting to a gynecological oncologist with a unilateral or bilateral pelvic mass (defined as a simple, complex, or a solid ovarian/pelvic mass) and scheduled to undergo surgery
    • Newly diagnosed epithelial ovarian cancer and undergoing first-line chemotherapy

    • History of epithelial ovarian carcinoma status post-primary chemotherapy treatment, currently in clinical remission according to the following criteria:

      • Absence of symptoms that may be related to disease
      • Imaging without abnormalities ≥ 1 cm suspicious for disease (no ascites)
      • CA125 obtained twice at least 3 weeks apart and not increasing by 50% and < 40 units/mL
    • Known BRCA mutations and intact ovaries (no prior bilateral salpingo-oophorectomy)

  • No synchronous primary endometrial cancer or a past history of primary endometrial cancer, unless all of the following conditions are met:

    • Stage not greater than IB
    • No more than superficial myometrial invasion, without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
  • No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • Patients of any stage who have recurred and are in second chemotherapy induced remission are not eligible

PATIENT CHARACTERISTICS:

  • Pre- or post-menopausal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancies within the past 5 years, with the exception of nonmelanoma skin cancer
  • No septicemia, severe infection, or acute hepatitis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No prior chemotherapy for another malignancy

Inclusion Criteria:

  • Eligible Patients
  • Patients age ≥ 21 years
  • Patients with a diagnosis of a pelvic mass (defined as a simple, complex or a solid ovarian / pelvic mass) who are scheduled to undergo surgery.
  • Patients with a new diagnosis of epithelial ovarian carcinoma undergoing primary chemotherapy treatment.
  • Patients with a history of epithelial ovarian carcinoma status post primary chemotherapy treatment, currently in clinical remission.
  • Patients with a known BRCA mutation and who have NOT undergone a bilateral salpingo-oophorectomy.
  • Clinical remission should require all of following:
  • Absence of symptoms that may be related to disease;
  • Imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no ascites);
  • CA 125 obtained x 2 at least 3 weeks apart and not increasing by 50% and < 40 units/mL.
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  • Women of childbearing potential must have a negative pregnancy test. They as well as their partners must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.

Exclusion Criteria:

  • Ineligible Patients
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients with synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
  • Patients with epithelial ovarian carcinoma of low malignant potential (Borderline carcinomas).
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or have received chemotherapy for another malignancy.
  • Patients of any stage who have recurred and are in second chemotherapy induced remission.
  • Patients with septicemia, severe infection, or acute hepatitis.
  • Patients who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biomarker testing
Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers.
Diagnostic test: Biomarker LPA and HE4
Non Interventional Trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of a new assay for lysophosphatidic acid (LPA)
Time Frame: 5 years
To develop a serum or plasma based assay to quantitate LPA levels
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
Time Frame: 5 years
To evaluate a quantitative serum LPA assay and correlate serum LPA levels in pre and post menopausal women with benign and malignant ovarian tumors.
5 years
LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
Time Frame: 5 years
To measure serum LPA levels in pre and postmenopausal women
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Richard G Moore, MD, Women and Infants Hospital of Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 26, 2009

First Submitted That Met QC Criteria

September 26, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIHRI-09-0030
  • CDR0000655148 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on Biomarker LPA and HE4

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe