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NCT06781151

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-04-24

Completion Date

2027-06-18

Last Updated

2025-08-27

Healthy Volunteers

No

Locations (2)

Sun Yat'sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, Guangdong, China