Clinical trial NCT06781151: A Study to Explore Personalized Treatment for Patients with Recurrent Gynecological Malignancies Based on MTB
Official title: A Real-world Study to Explore Personalized Treatment for Patients with Recurrent Gynecological Malignancies Based on Molecular Profiling and Multidisciplinary Team Consultation
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recurrent ovarian, cervical, or endometrial cancer referred for multidisciplinary consultation by a gynecological oncologist

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the overall response rate
timeFrame: 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:
measure: the progression free survival (PFS)
timeFrame: 2 years
measure: the overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat'sen University Cancer Center
state: Guangdong
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
state: Guangdong
Study officials:
affiliation: Sun Yat'sen University Cancer Center
name: Jihong Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: