Ignite Creation Date:
2024-05-05 @ 9:54 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00986206
Status:
COMPLETED
Last Update Posted:
2018-01-05
First Post:
2009-09-26
Brief Title:
Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
Development of an Assay for the Early Detection of Ovarian Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 chromatographyelectrospray 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
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 chromatographyelectrospray 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000655148 | REGISTRY | PDQ Physician Data Query | None |