Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorWest China Second University Hospital

About this trial

Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75;

Pathologically confirmed ovarian cancer;

CA125 ≤200U/ml at first diagnosis or recurrence;

Physical condition score PS ≤ 2 points;

Disqualifiers

Patients unable to provide sufficient tissue / blood samples for research detection;

Pregnant or lactating women;

Other diseases considered by the research doctor to affect the prognosis and survival;

Trial population

This study intends to include 35 patients with low CA125 level ovarian cancer at first diagnosis or recurrence between the ages of 18-75 years old.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

35 Participants
are grouped into 1 trial group
Group A: ctDNA alternation during the treatment of Ovarian cancer

Trial outcomes

Primary outcomes

1

The prognostic value of MRD

The sensitivity of MRD in CA125 low level ovarian patients.

Time frame
12 months

Secondary outcomes

1

Progress Free Survival

PFS differences in patients with different MRD level

Time frame
From date of the beginning of therapy to disease metastasis or recurrence due to any cause,assessed up to 24 months

Other outcomes

Sponsors and contacts

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