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CA 125 Blood Test for Early Detection of Ovarian Cancer

N/A
Recruiting
Led By Karen H. Lu, MD
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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of increase in CA 125 levels 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%
Hand-foot syndrome
54%
Mucositis oral
54%
Anemia
46%
Dysgeusia
44%
Nausea
41%
Rash
39%
Proteinuria
39%
Neutrophil count decreased
36%
Creatinine increased
32%
Aspartate aminotransferase increased
27%
Hypertension
25%
Hypothyroidism
24%
Vomiting
22%
Dyspepsia
20%
Hypoalbuminemia
20%
Anorexia
20%
Dyspnea
20%
Skin hypopigmentation
19%
Alanine aminotransferase increased
17%
Watering eyes
15%
Edema
14%
Weight loss
14%
Oral dysesthesia
14%
Epistaxis
14%
Pruritus
12%
Hyperglycemia
12%
Gastroesophageal reflux disease
12%
Lymphocyte count decreased
12%
Hypocalcemia
10%
Blood bilirubin increased
10%
Dysesthesia
10%
Alkaline phosphatase increased
10%
Constipation
10%
Headache
8%
Hyponatremia
8%
TSH increased
7%
Dry skin
7%
Anal mucositis
7%
Hypomagnesemia
7%
Hair hypopigmentation
7%
Myalgia
7%
Dry mouth
7%
Non-cardiac chest pain
7%
Paresthesia
5%
Bloating
5%
Thromboembolic event
5%
Alopecia
5%
CD4 lymphocytes decreased
5%
Hyperkalemia
5%
Thrombotic thrombocytopenic purpura
5%
Abdominal pain
5%
Hemoglobinuria
2%
Dehydration
2%
Vascular access complication
2%
Hypophosphatemia
2%
Gout
2%
Pancreatic insufficiency
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sunitinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: CA 125 AnalysisExperimental Treatment1 Intervention
Participants will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers. Depending on CA-125 level: Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year. Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks. Questionnaires completed at baseline and during each follow up visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaire
2014
Completed Phase 2
~19970

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,786,279 Total Patients Enrolled
46 Trials studying Ovarian Cancer
8,745 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,951,401 Total Patients Enrolled
288 Trials studying Ovarian Cancer
65,705 Patients Enrolled for Ovarian Cancer
Golfers Against CancerUNKNOWN
~1268 spots leftby Nov 2028
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