Cervical Cancer Recurrent, Endometrial Cancer Recurrent, Ovarian Cancer Recurrent
Conditions
Keywords
genomic sequencing, molecular tumor boards, recurrent ovarian cancer, recurrent endometrial cancer, recurrent cervical cancer
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.
Interventions
None listed
Sponsors
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Obstetrics & Gynecology Hospital of Fudan University
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the overall response rate | 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
| Measure | Time frame | Description |
|---|---|---|
| the progression free survival (PFS) | 2 years | the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever comes first. |
| the overall survival (OS) | 2 years | a measure of the length of time from the start of treatment until death from any cause |
Countries
China
Contacts
Primary ContactXiaolin Luo, PhD
Outcome results
None listed