Actively Recruiting

Age: 18Years +
FEMALE
NCT06781151

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

Led by Sun Yat-sen University · Updated on 2025-08-27

200

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

C

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients with concurrent malignancies
  • Pregnant patients

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sun Yat'sen University Cancer Center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

X

Xiaolin Luo, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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