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NCT Number: NCT06781151

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients with concurrent malignancies;
  • Pregnant patients.

Treatment and study plan

Primary outcomes

  1. the overall response rate

    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

    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

Secondary outcomes

  1. the progression free survival (PFS)

    Time frame: 2 years

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

  2. the overall survival (OS)

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaolin Luo, PhD

CONTACT

[email protected]

15017599965

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
  • Obstetrics & Gynecology Hospital of Fudan University

Registry information

Official study title

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

Acronym: RWS-MTB

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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