Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05027828
Other study ID # XH-21-008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date September 30, 2024

Study information

Verified date April 2023
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Ovarian cancer first diagnosed and treated; 2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer; 3. The stage of the disease is II-IV, and surgery will be performed after evaluation; 4. Age = 18 years old; 5. Subjects and their families fully understand the research plan and sign an informed consent form. Exclusion Criteria: 1. Pathologically confirmed as non-epithelial ovarian cancer; 2. Surgical treatment cannot be performed after evaluation; 3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment; 4. Patients who do not agree to use clinical first-line targeted drugs; 5. Severe mental illness; 6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

Study Design


Locations

Country Name City State
China Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing. about 36 months after using PARP inhibitors
Secondary Overall survival about over 5 years after using PARP inhibitors
Secondary Objective response rate To evaluate the general response of patients with ovarian cancer to PARP inhibitors 36 months after using PARP inhibitors
See also
  Status Clinical Trial Phase
Recruiting NCT05167604 - Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
Recruiting NCT05598528 - Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Recruiting NCT04555369 - The Value of ctDNA on Chemotherapy Efficacy for mCRC N/A
Not yet recruiting NCT03688035 - Potential of Circulating Tumor DNA to Assess the Tumor Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Recruiting NCT03737539 - Dynamic Monitoring of ctDNA Methylation to Predict Relapse in Colorectal Cancer After Radical Resection (POSTCA)
Not yet recruiting NCT04511559 - Methylation Analysis of Circulating Tumor DNA in Gastric Cancer
Recruiting NCT03748680 - IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer Phase 2
Completed NCT02620527 - Concordance Between ctDNA Assay and FoundationOne
Recruiting NCT05529615 - Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer N/A
Recruiting NCT05601505 - Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer Phase 2
Recruiting NCT05161585 - Evaluation of Circulating Tumor DNA Guided Surveillance Strategy of Stage III Colorectal Cancer: an Open, Prospective, Randomized Controlled Cohort Study N/A
Recruiting NCT05390112 - Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization
Recruiting NCT06434896 - Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial N/A
Recruiting NCT04966663 - Using ctDNA to Determine Therapies for Lung Cancer Phase 2
Recruiting NCT05801263 - ctDNA Methylation for Epithelial Ovarian Cancer
Recruiting NCT05801276 - ctDNA Methylation for Detecting Ovarian Cancer
Active, not recruiting NCT04276337 - Genetic Characteristics of HER2 Positive Breast Cancer With Neoadjuvant TCHP Chemotherapy
Recruiting NCT05969938 - Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology
Completed NCT04456972 - Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers. N/A
Completed NCT06404593 - Dynamic ctDNA Detection for Colorectal Cancer Liver Metastases