Ovarian CancerNCT00628654
Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants
An observational study of Ovarian Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer. PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to 10 Mar 2016
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: volunteers and patients with ovarian, peritoneal, and fallopian tube cancers
Who may be able to join
- Able to understand consent document for participation in the study
- Not pregnant
- Negative pregnancy test
- Participants must meet 1 of the following criteria:
- Patients scheduled for ovarian surgery for an ovarian mass
- Healthy female volunteers with no active cancer or history of cancer
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.
PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.
Secondary
- Compare the new assay to the standard CA 125 for diagnostic accuracy.
OUTLINE:
- Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
- Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.
PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.
- Conditions
- Ovarian Cancer
- Keywords
- ovarian germ cell tumor, 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.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire. | |
| Patients with cancer | Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of glycan analysis
For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).
Measured: one time for healthy volunteers; up to 2 years for patients with cancer
Secondary outcomes (1)
Comparison of the new assay to the standard CA 125 assay
For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).
Measured: one time for healthy volunteers; up to 2 years for patients with cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startOct 2005
- Primary completion10 Mar 2016
- Study completion10 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary Leiserowitz, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628654
- Sponsor's protocol ID
- 251975
- Other IDs
- CDR0000583063, UCD-183, UCD-200513707, P30CA093373
- Status last verified
- Jan 2019
- First submitted
- 4 Mar 2008
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Protocol to Evaluate Glycans Analysis As a Diagnostic Test for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00628654
- Acronym / sponsor ID
- 251975
- Conditions
- Ovarian Cancer
- Keywords
- ovarian germ cell tumor, ovarian epithelial cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- 10 Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 5 Mar 2008 (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: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.
PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.
Detailed description
OBJECTIVES:
Primary
- Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.
Secondary
- Compare the new assay to the standard CA 125 for diagnostic accuracy.
OUTLINE:
- Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
- Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.
PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –Serum samples will be obtained from volunteers, but no tissue specimens. Volunteers will complete a questionnaire. |
| Patients with cancer | – | –Ascites from patients with ovarian, peritoneal, and fallopian tube cancers for basic science studies |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- volunteers and patients with ovarian, peritoneal, and fallopian tube cancers
Key inclusion criteria (6 listed)
- Able to understand consent document for participation in the study
- Not pregnant
- Negative pregnancy test
- Patients scheduled for ovarian surgery for an ovarian mass
- Healthy female volunteers with no active cancer or history of cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of glycan analysis
Time frame: one time for healthy volunteers; up to 2 years for patients with cancer
For healthy controls, a single sample will be obtained. For patients scheduled for surgery, two samples will be obtained: one preoperatively and one postoperatively. Ovarian cancer patients who agree to participate in the longitudinal study will have follow-up serum samples drawn periodically during chemotherapy treatments and then during surveillance visits, to correspond with routine blood testing for CA 125. They will be asked to participate for 2 years, with a maximum of 8 blood draws per year (to be coordinated with other venipunctures, if possible).
1 secondary outcome
Comparison of the new assay to the standard CA 125 assay
Time frame: one time for healthy volunteers; up to 2 years for patients with cancer
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 4 Jan 2019.
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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.
Gary Leiserowitz, MD principal investigator
University of California, Davis
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 Ovarian Cancer, run by University of California, Davis 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 6 inclusion and 0 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 4 Jan 2019. 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?
Accuracy of glycan analysis (time frame: one time for healthy volunteers; up to 2 years for patients with cancer). 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 4 Jan 2019.