brca1 Mutation CarrierNCT00986206
Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer
An observational study of brca1 Mutation Carrier and brca2 Mutation Carrier, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Ovarian Cancer
- What is being tested?
- Biomarker LPA and HE4
- How many people
- 525 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women presenting with a pelvic mass and scheduled to undergo surgery.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: 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.
Read the 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.
- Being tested
- Biomarker LPA and HE4
- 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
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker LPA and HE4Diagnostic test
Non Interventional Trial
| Study group | Role | What they receive |
|---|---|---|
| Biomarker testing | Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers. Receives: Diagnostic Test: Biomarker LPA and HE4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of a new assay for lysophosphatidic acid (LPA)
To develop a serum or plasma based assay to quantitate LPA levels
Measured: 5 years
Secondary outcomes (2)
Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
To evaluate a quantitative serum LPA assay and correlate serum LPA levels in pre and post menopausal women with benign and malignant ovarian tumors.
Measured: 5 years
LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
To measure serum LPA levels in pre and postmenopausal women
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard G. Moore, MD, Women and Infants Hospital of Rhode Island
- Investigators
- Richard G Moore, MD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986206
- Sponsor's protocol ID
- WIHRI-09-0030
- Other IDs
- CDR0000655148
- Status last verified
- Jan 2018
- First submitted
- 26 Sep 2009
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Assay for the Early Detection of Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT00986206
- Acronym / sponsor ID
- WIHRI-09-0030
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker testing | – | Diagnostic Test: Biomarker LPA and HE4Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women presenting with a pelvic mass and scheduled to undergo surgery.
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker LPA and HE4Non Interventional Trial | Diagnostic test | Biomarker testing |
Primary outcome
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
2 secondary outcomes
Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women
Time frame: 5 years
LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard G Moore, MD principal investigator
Women and Infants Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of brca1 Mutation Carrier and brca2 Mutation Carrier, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a new assay for lysophosphatidic acid (LPA) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.