Clinical trial NCT06283875: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer
Official title: A Prospective, Single Center Clinical Study on the Clinical Significance of Personalized ctDNA-MRD in Predicting the Efficacy and Monitoring the Risk of Recurrence of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Keywords: ctDNA
MRD
cervical carcinoma
operation
Radical radiotherapy and chemotherapy
Efficacy prediction
Recurrence monitoring
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study focuses on newly diagnosed cervical cancer patients who have been confirmed by histology or cytology to undergo surgical resection or curative radiotherapy and chemotherapy in locally advanced stages (stages IB-IV). A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the curative treatment measures that patients can accept, the enrolled patients are divided into a operable treatment queue (N=40) and a curative radiotherapy and chemotherapy treatment queue (N=40).

Brief summary: This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS.

Detailed description: Surgical treatment cohort (N=40):

Collect surgical tumor tissue samples from the screening stage of patients in this cohort, as well as peripheral blood samples (20 ml/time) from baseline, postoperative, postoperative radiotherapy and chemotherapy, consolidation therapy (if any), and a 2-year follow up with 6 months/time . (A total of one tissue sample, 7-8 peripheral blood samples )

Radical radiotherapy and chemotherapy treatment cohort (N=40):

Radical radiotherapy and chemotherapy cohort: Collect baseline tumor tissue samples from patients during the screening stage, as well as peripheral blood samples (20 ml/time) from baseline, mid-term of radical radiotherapy and chemotherapy, after radical radiotherapy and chemotherapy, after consolidation treatment (if any), and a 2-year follow-up stage of 6 months/time. (A total of one tissue sample, 7-8 peripheral blood samples )

If you voluntarily participate in this study, we will require your cooperation in completing the following tasks: the entire research process consists of a screening period and a follow-up period, and it will take approximately 5 years for you to complete the entire research period. If you are willing to participate in this study, we will obtain your surgical tissue samples and obtain peripheral blood samples (20 ml/time) from a total of 7-8 times during your 5-year follow-up. The MRD detection results of each timepoint throughout the entire trial process will be promptly fed back to you and your clinical doctors for your clinical treatment plan decision-making. Before formulating your clinical treatment plan, the clinical doctor will provide you with detailed information, discussion, and confirmation. Only after receiving your confirmation can you proceed with the implementation. Throughout the entire research process, we will promptly provide you with any information such as detection indicators that may affect your decision-making. You also have the right to withdraw from this study at any time without retaliation, discrimination, or any other unfair treatment. We will protect any personal privacy information of you.

If you participate in this study, you will receive a total of 6-7 free peripheral blood based deep ctDNA-MRD tests (valued at 3800 yuan/test) throughout your entire treatment and follow-up stages. Through continuous monitoring of peripheral blood ctDNA-MRD nodes, you can advance imaging to indicate your risk of disease recurrence, detect disease progression as soon as possible, effectively improve your treatment effectiveness and clinical benefits, and evaluate your treatment efficacy as soon as possible Prognosis assessment may lead to more effective control or improvement of your personal disease treatment and quality of life. The detection results of each time will be promptly fed back to you and your research doctors to assist in your clinical decision-making and disease risk warning. Meanwhile, your participation in this study may also contribute to the improvement of solid tumor diagnosis and treatment techniques, which may bring benefits to other patients in the future.

Eligibility criteria: Inclusion Criteria:

* (1) Confirmed by histopathology and classified as stage IB-IVA cervical cancer patients according to the 2018 FIGO staging criteria;

  (2) Patients can receive surgical treatment or curative radiotherapy and chemotherapy;

  (3) Age range from 18 to 80 years old;

  (4) General condition: ECOG 0-2;

  (5) At least one measurable lesion (RECIST 1.1 standard);

  (6) Be able to understand the research plan and voluntarily participate in this study, and sign an informed consent form;

  (7) Good compliance, able to cooperate in collecting specimens from various nodes and provide corresponding clinical information;

  (8) Having comprehensive clinical data on imaging and pathology;

  (9) The estimated survival time of the patient is greater than 3 months;

  (10) Having sufficient organ and bone marrow functions.

Exclusion Criteria:

* 1) Within 5 years, suffering from other malignant tumors or metastatic or recurrent cervical cancer;

  (2) Has received any tumor treatment plan in the past;

  (3) Surgical resection or curative radiotherapy and chemotherapy are not acceptable;

  (4) Unable to follow the determined clinical follow-up period in conjunction with the study for follow-up;

  (5) Inability to accept or provide specified efficacy evaluation methods such as CT;

  (6) Suffering from autoimmune diseases;

  (7) Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;

  (8) Subjects with any severe and/or uncontrolled diseases;

  (9) According to the researchers judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the subjects

Primary outcomes:
measure: DFS of enrolled patients for 2 years
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University，Director of Gynecology Department
name: Jinhua Zhou
role: PRINCIPAL_INVESTIGATOR
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