NCT06781151 A Study to Explore Personalized Treatment for Patients With Recurrent Gynecological Malignancies Based on MTB
| NCT ID | NCT06781151 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Ovarian Cancer Recurrent |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-04-24 |
| Primary Completion | 2026-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-04-24 with a primary completion date of 2026-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Jihong Liu, PhD
PRINCIPAL INVESTIGATOR
Sun Yat'sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06781151 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer Recurrent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06781151 currently recruiting?
Yes, NCT06781151 is actively recruiting participants. Contact the research team at luoxl@sysucc.org.cn for enrollment information.
Where is the NCT06781151 trial being conducted?
This trial is being conducted at Guangzhou, China, Shenzhen, China.
Who is sponsoring the NCT06781151 clinical trial?
NCT06781151 is sponsored by Sun Yat-sen University. The principal investigator is Jihong Liu, PhD at Sun Yat'sen University Cancer Center. The trial plans to enroll 200 participants.
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