Health TrialsbyHealthPanel

Specimen and Data Study for Ovarian Cancer Early Detection and Prevention

ConditionsCervical CancerEndometrial CancerFallopian Tube CancerHereditary Breast/Ovarian Cancer (brca1, brca2)Ovarian CancerSarcomaUterine LeiomyomataVaginal CancerVulvar Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorNorthwestern University

About this trial

RATIONALE: To improve strategies for detection and prevention of early-stage disease.

PURPOSE: This research study is collecting specimens and data to develop better methods for early detection and prevention of ovarian cancer among the high risk population and those who have the disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Has at least one first-degree relative (mother, sister, or daughter) with ovarian, primary peritoneal, or fallopian tube cancer

Has at least two first or second degree relatives diagnosed before age 50 with either ovarian, primary peritoneal, fallopian tube, and/or pancreatic cancer who have tested positive for hereditary cancer syndrome that includes an increased risk of gynecologic cancer (e.g., BRCA1/2 or Lynch Syndrome)or have increased risk as deemed by a certified genetic counselor

A personal or family history of a hereditary cancer syndrome that includes an increased risk of gynecologic cancer

Increased risk as deemed by a certified genetic counselor

Disqualifiers

None

Trial population

Women at high risk of ovarian cancer due to family or personal medical history, or a gynecologic abnormality.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Ca-125

    Other intervention

    Subject's blood collected at their follow-up blood draw will be assessed for biomarkers that could lead to a panel for detecting early stage ovarian cancer.

  • screening questionnaire administration

    Other intervention

    Questionnaires designed to assess quality of life for women at increased risk of ovarian cancer will be administered to the subjects. Clinical data will also be collected.

  • Surgery

    Procedure/Surgery

    Subjects will be assessed for high risk factors.

Treatment groups

6,000 Participants
are divided into 3 treatment groups
Group A: High Risk for Ovarian Cancer3 interventions
Group B: Suspected or diagnosed gynecological condition0 interventions
Group C: Control Group0 interventions

Trial outcomes

Primary outcomes

1

The development of ultrasound and serum tumor markers for the detection and management of ovarian cancer and other

To identify markers to allow for presymptomatic testing for ovarian and other gynecological malignancies

Time frame
1 year

Secondary outcomes

1

new prevention approaches and therapies for risk assessment

To identify new prevention approaches and therapies by researching and reviewing the risk of developing disease.

Time frame
1 year
2

The develop of measures to improve the quality of life for women at increased risk for developing the disease and for women diagnosed with ovarian cancer

To identify the measurements to improve the quality of life for women at increased risk for developing the disease

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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