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CA 125 Blood Test for Early Detection of Ovarian Cancer

N/A

Recruiting

Led By Denise Nebgen, MD, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have at least one ovary

Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study

Must not have

Prior removal of both ovaries

High risk for ovarian cancer due to familial predisposition as defined by specific criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up based on ca-125 level, 3 options will result: 1) re-draw blood (ca-125) in 1 year, 2) re-draw blood (ca-125) in 3 months), or 3) re-draw blood (ca-125) and tvus in 6 weeks +/- 2 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a blood test can detect ovarian cancer early in women who are at low risk.

Who is the study for?

This trial is for women aged 50-75 who are postmenopausal, have at least one ovary, and haven't had cancer or cancer treatments in the last year. Participants must be willing to take annual blood tests and possibly a transvaginal ultrasound if needed. They should not have conditions preventing informed consent, both ovaries removed, high genetic risk for ovarian cancer, or active non-ovarian malignancies.

What is being tested?

The study is testing whether a blood test called CA-125 can help detect ovarian cancer early in low-risk women. Participants will complete questionnaires and undergo regular CA-125 blood tests with follow-up procedures like ultrasounds if results suggest further examination is necessary.

What are the potential side effects?

There may be minimal side effects related to the blood draw procedure such as bruising or discomfort at the puncture site. The transvaginal ultrasound might cause some discomfort during insertion of the probe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one ovary.

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I have been cancer-free and haven't had chemo or radiation for at least 12 months.

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I have not had a menstrual period for at least 12 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had both of my ovaries removed.

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I am at high risk for ovarian cancer due to my family history.

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I am a woman under 50 or over 75 years old.

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I have an active cancer that is not ovarian cancer.

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I have a genetic condition linked to a high risk of colon cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ based on ca-125 level, 3 options will result: 1) re-draw blood (ca-125) in 1 year, 2) re-draw blood (ca-125) in 3 months), or 3) re-draw blood (ca-125) and tvus in 6 weeks +/- 2 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~based on ca-125 level, 3 options will result: 1) re-draw blood (ca-125) in 1 year, 2) re-draw blood (ca-125) in 3 months), or 3) re-draw blood (ca-125) and tvus in 6 weeks +/- 2 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and based on ca-125 level, 3 options will result: 1) re-draw blood (ca-125) in 1 year, 2) re-draw blood (ca-125) in 3 months), or 3) re-draw blood (ca-125) and tvus in 6 weeks +/- 2 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of increase in CA 125 levels and other tumor markers over time

Side effects data

From 2019 Phase 2 trial • 60 Patients • NCT02060370

83%

Fatigue

76%

Diarrhea

61%

Platelet count decreased

58%

White blood cell decreased

54%

Anemia

54%

Mucositis oral

54%

Hand-foot syndrome

46%

Dysgeusia

44%

Nausea

41%

Rash

39%

Neutrophil count decreased

39%

Proteinuria

36%

Creatinine increased

32%

Aspartate aminotransferase increased

27%

Hypertension

25%

Hypothyroidism

24%

Vomiting

22%

Dyspepsia

20%

Dyspnea

20%

Hypoalbuminemia

20%

Anorexia

20%

Skin hypopigmentation

19%

Alanine aminotransferase increased

17%

Watering eyes

15%

Edema

14%

Epistaxis

14%

Oral dysesthesia

14%

Pruritus

14%

Weight loss

12%

Lymphocyte count decreased

12%

Hyperglycemia

12%

Gastroesophageal reflux disease

12%

Hypocalcemia

10%

Constipation

10%

Headache

10%

Alkaline phosphatase increased

10%

Dysesthesia

10%

Blood bilirubin increased

TSH increased

Hyponatremia

Dry skin

Non-cardiac chest pain

Paresthesia

Anal mucositis

Dry mouth

Hypomagnesemia

Myalgia

Hair hypopigmentation

Thromboembolic event

CD4 lymphocytes decreased

Abdominal pain

Alopecia

Bloating

Hemoglobinuria

Hyperkalemia

Thrombotic thrombocytopenic purpura

Pancreatic insufficiency

Gout

Dehydration

Urticaria

Hypophosphatemia

Vascular access complication

100%

80%

60%

40%

20%

Study treatment Arm

Sunitinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CA 125 AnalysisExperimental Treatment1 Intervention

Experimental: CA 125, HE4, HE4 antigen autoantibody complexes, and Osteopontin Analysis Participants will have blood (3-4 tablespoons) drawn for CA125 and other tumor markers. Depending on CA-125 level and other tumor markers: Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year. Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaire

2014

Completed Phase 2

~19970

0 / 8Eligibility criteria met