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

NCT00986206 | Completed

• 2 other identifiers: WIHRI-09-0030CDR0000655148
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer

Keywords

ovarian epithelial cancer; BRCA1 mutation carrier; BRCA2 mutation carrier; stage IA ovarian epithelial cancer; stage IB ovarian epithelial 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

Outcome Measures

Primary Outcomes (1)

• Validation of a new assay for lysophosphatidic acid (LPA)

  To develop a serum or plasma based assay to quantitate LPA levels

  5 years

Secondary Outcomes (2)

• Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women

  5 years

• LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer

  5 years

Study Arms (1)

Biomarker testing

Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers.

Diagnostic Test: Biomarker LPA and HE4

Interventions

Biomarker LPA and HE4 DIAGNOSTIC_TEST

Non Interventional Trial

Biomarker testing

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Plasma, Urine

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard G Moore, MD

  Women and Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncologist

Study Record Dates

• First Submitted: September 26, 2009
• First Posted: September 29, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

US (1)