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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
Female, >/= 50 years old or less than 75 years old
Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
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

Study 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 am a woman aged between 50 and 75.
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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.
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I have at least one ovary.

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%
Anemia
54%
Hand-foot syndrome
54%
Mucositis oral
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%
Skin hypopigmentation
20%
Anorexia
20%
Hypoalbuminemia
19%
Alanine aminotransferase increased
17%
Watering eyes
15%
Edema
14%
Epistaxis
14%
Pruritus
14%
Oral dysesthesia
14%
Weight loss
12%
Gastroesophageal reflux disease
12%
Lymphocyte count decreased
12%
Hyperglycemia
12%
Hypocalcemia
10%
Constipation
10%
Headache
10%
Alkaline phosphatase increased
10%
Blood bilirubin increased
10%
Dysesthesia
8%
TSH increased
8%
Hyponatremia
7%
Hypomagnesemia
7%
Anal mucositis
7%
Hair hypopigmentation
7%
Myalgia
7%
Dry skin
7%
Dry mouth
7%
Non-cardiac chest pain
7%
Paresthesia
5%
Bloating
5%
Hyperkalemia
5%
Thromboembolic event
5%
Alopecia
5%
Thrombotic thrombocytopenic purpura
5%
Abdominal pain
5%
Hemoglobinuria
5%
CD4 lymphocytes decreased
2%
Dehydration
2%
Gout
2%
Pancreatic insufficiency
2%
Urticaria
2%
Hypophosphatemia
2%
Vascular access complication
100%
80%
60%
40%
20%
0%
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
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
~20090

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,945 Previous Clinical Trials
1,795,381 Total Patients Enrolled
46 Trials studying Ovarian Cancer
8,745 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,577 Previous Clinical Trials
41,216,400 Total Patients Enrolled
284 Trials studying Ovarian Cancer
64,918 Patients Enrolled for Ovarian Cancer
Golfers Against CancerUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this trial involving participants?

"Affirmative. The information on clinicaltrials.gov attests to the fact that this medical trial, initially listed on July 2nd of 2001, is actively searching for candidates. A total of 8000 patients will be enrolled from 11 distinct sites."

Answered by AI

Are there any available slots still accessible for participants in this investigation?

"Affirmative. Details posted on clinicaltrials.gov show that this medical study, initially published on July 2nd 2001, is accepting volunteers as we speak. A total of 8000 participants from 11 different trial sites are needed for the experiment to be completed successfully."

Answered by AI

Is the minimum age for participation in this medical research set at 35 years or below?

"The study's entry requirements indicate that only those between 50 and 74 years of age are eligible to participate."

Answered by AI

What is the scope of medical establishments engaging in this clinical investigation?

"Currently, 11 clinical trial sites are running this study. Patients can select a location near them to reduce the amount of travel needed for participation; these locations include Dallas, Houston, and San Antonio as well as 8 other places."

Answered by AI

Who is eligible to enroll in this research trial?

"Candidates accepted into this clinical trial must be aged between 50 and 74 and suffer from ovarian cancer. With the aim of recruiting 8000 individuals, applications are currently being considered."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Oklahoma Health Sciences Center

Why did patients apply to this trial?

I've had problems with my ovaries and cervix all my life plus I NEED to make some money.
PatientReceived 2+ prior treatments
~1390 spots leftby Nov 2028