Clinical trial NCT00986206: Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Official title: Development of an Assay for the Early Detection of Ovarian Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 525
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presenting with a pelvic mass and scheduled to undergo surgery.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Validation of a new assay for lysophosphatidic acid (LPA)
timeFrame: 5 years
Secondary outcomes:
measure: Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
timeFrame: 5 years
measure: LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital of Rhode Island
name: Richard G Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: