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

NCT06781151 | Recruiting

• 1 other identifier: 2023-FXY-274
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Ovarian Cancer Recurrent; Endometrial Cancer Recurrent; Cervical Cancer Recurrent

Keywords

genomic sequencing; molecular tumor boards; recurrent ovarian cancer; recurrent endometrial cancer; recurrent cervical cancer

Outcome Measures

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

  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 (2)

• the progression free survival (PFS)

  2 years

• the overall survival (OS)

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with concurrent malignancies;
• Pregnant patients.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator
• Obstetrics & Gynecology Hospital of Fudan University: collaborator

Study Sites (2)

Sun Yat'sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Uterine Cervical Diseases

Study Officials

• Jihong Liu, PhD

  Sun Yat'sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaolin Luo, PhD

CONTACT

15017599965; luoxl@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 17, 2025
• Study Start: April 24, 2024
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): June 18, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)