A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSun Yat-sen University

About this trial

This is a non-interventional, real-world study divided into two parts: a retrospective study and a prospective study.

The main question it aims to answer is:

Will genomic sequencing and molecular tumor boards lead to clinical responses in patients with recurrent ovarian, cervical, or endometrial cancer? The retrospective arm will analyze data from patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) who underwent multidisciplinary consultations at our institution from January 2022 onward. Data collected will include tumor tissue genomic sequencing results, medical histories, multidisciplinary consultation recommendations, and subsequent treatment courses. This analysis will examine the implementation and clinical efficacy of personalized targeted therapies guided by molecular tumor profiling and multidisciplinary consultation.

The prospective arm will enroll 200 patients with recurrent gynecological malignancies (ovarian, cervical, or endometrial) referred for multidisciplinary consultation. Tumor tissue and blood samples will undergo next-generation sequencing (NGS) to determine molecular tumor profiles. A multidisciplinary expert panel will formulate individualized treatment strategies based on these profiles, patient clinical data, and treatment history. Attending physicians will determine the final treatment plan, integrating multidisciplinary recommendations with patient preferences, comorbidity considerations, drug toxicity assessments, insurance coverage for off-label medications, and the availability of investigational drug trials. This arm aims to observe and evaluate the clinical efficacy of personalized treatment plans developed through molecular tumor profiling and multidisciplinary consultation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist;

Presence of at least one evaluable lesion;

Willingness to participate in multidisciplinary consultation;

Age 18 years or older;

Disqualifiers

Patients with concurrent malignancies;

Pregnant patients.

Trial population

Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

the overall response rate

the overall response rate (ORR) by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans

Time frame
an assessment was performed at the end of Cycle 2 or Cycle 3 or Cycle 4 (each cycle is 21-28 days) according to the actual situation

Secondary outcomes

1

the progression free survival (PFS)

the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever comes first.

Time frame
2 years
2

the overall survival (OS)

a measure of the length of time from the start of treatment until death from any cause

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Collaborator

Obstetrics & Gynecology Hospital of Fudan University

Collaborator