Protein 'Fingerprint' blood test could warn of ovarian cancer return

NCT ID NCT00086567

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 7 times

Summary

This study looks at proteins in the blood of women with ovarian, peritoneal, or fallopian tube cancer who are in remission. The goal is to find a protein pattern, or 'fingerprint,' that signals when the cancer might come back. Researchers followed 119 women with stage III or IV cancer for up to 4 years, taking blood samples and scans every few months. If a reliable fingerprint is found, it could lead to a simple blood test to catch relapses early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test that helps doctors predict when ovarian cancer might return, allowing for earlier intervention.
What could go wrong
This is an observational study, not a treatment trial. The protein fingerprint approach is still in early development and may not prove reliable enough for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

119 people

The number who actually took part.

Started

Dec 2005

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: 2.1.1\<TAB\>All patients in first complete response from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by: normal CA-125, normal post-hysterectomy physical exam, no evidence of disease on abdominopelvic CT scan (or other noninvasive reassessment, e.g. MRI). PET scans are not acceptable for confirmation of complete response. 2.1.2\<TAB\>Pathology of the primary tumor must be confirmed by the registering center prior to protocol entry. 2.1.3\<TAB\>Entry within 9 weeks of completion of final cycle of chemotherapy (within 12 weeks of last administration of chemotherapy). 2.1.4\<TAB\>S/P surgical debulking and completion of primary therapy with platinum/taxane -containing chemotherapy of no more than 8 total cycles. 2.1.5\<TAB\>Patients who undergo second look laparotomy or laparoscopy and have microscopic residual disease but who elect not to have treatment will be eligible to enroll. 2.1.6\<TAB\>Histology slides adequate to confirm the pathology and staging must be submitted to the coordinating center within 3 months of enrollment. (If available, a sample of frozen primary tumor should also be forwarded). 2.1.7\<TAB\>Patients must be able and willing to provide informed consent to participate in the trial. 2.1.8\<TAB\>Patients must have laboratory evidence of good end organ function by criteria in Table 1 below. The upper limit of normal is based upon each registering center's laboratory normal ranges. Laboratory based inclusion criteria: Laboratory Test: AST(SGOT) and ALT(SGPT) Required value: less than or equal to 2.5 times the institutional upper limit of normal creatinine OR Laboratory Test: Creatinine Required value: Less than or equal to 2.0 Laboratory Test: Creatinine clearance Required Value: Greater than or equal to 45 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal. EXCLUSION CRITERIA: 2.2.1\<TAB\>Patients with nonepithelial ovarian cancer, mixed epithelial/nonepithelial ovarian cancer (i.e., Mixed Malignant Mullerian Tumors), or tumors of low malignant potential. Patients with stage I or II epithelial ovarian, fallopian tube, or primary peritoneal cancer. 2.2.2\<TAB\>Patients may not be receiving chemotherapy (therapeutic or consolidation), maintenance, alternative therapy, or radiation therapy. No anti-cancer therapy of any kind is allowed while the patient is on-study. Replacement hormonal therapy is allowed but must be clearly indicated on the case report forms submitted. Hormonal anti-cancer therapies such as tamoxifen and raloxifene will not be permitted while on study. 2.2.3\<TAB\>Patients with a life expectancy of less than 6 months for any reason. 2.2.4 \<TAB\>Patients with a history of other invasive malignancies within the past five years prior to enrollment except for curatively treated carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, concomitant stage I endometrial cancer, or basal or squamous cell skin cancers. 2.2.5 \<TAB\>Complementary and alternative agent use is discouraged on this study due to the possibility that the use of these agents may alter the serum protein pattern. The Institutional Principal Investigator will have discretion as to whether complementary or alternative agent usage will prevent eligibility on a case by case basis.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048-1804, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Evanston Northwestern University Hospital

    Evanston, Illinois, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Massachusetts General Hospital, Dana Farber

    Boston, Massachusetts, 02114, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • New York University School of Medicine

    New York, New York, 10016, United States

  • Pacific Ovarian Cancer Research Consortium at FHCRC

    Seattle, Washington, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Washington/Fred Hutchinson Cancer Research Center

    Seattle, Washington, 28104, United States

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