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NCT06781151Recruiting

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

A Real-world Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on Molecular Profiling and Multidisciplinary Team Consultation

Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
5 Jan 2025
Start date
24 Apr 2024
Primary completion date
18 Dec 2026
Lead sponsor
Sun Yat-sen University
NCT number
NCT06781151

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 24 Apr 2024 to the primary completion date, 18 Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with concurrent malignancies;

Other

  • Pregnant patients.

Who the study is looking for

  • 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;
  • Sufficient tumor tissue for next-generation sequencing (NGS) with a tumor content greater than 32%;
  • Informed consent provided by the participant, indicating understanding of the study procedures and willingness to participate.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
Coordinator of this site? Confirm its status
ShenzhenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.