Clinical Trials Logo
  1. Home
  2. Ovarian Cancer
  3. NCT05446545

Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer — EOC  

Ovarian Cancer Clinical Trial

Official title:
Evaluation of Prognostic and Predictive Values of Bespoke Circulating Tumor DNA Assay for Recurrent and Response Monitoring in Patients With Advanced Epithelial Ovarian Cancer

Clinical Trial Summary

This prospective observational study is to assess the dynamics of circulating tumor DNA (ctDNA) in patients with advanced epithelial ovarian cancer (EOC) undergoing surgery, adjuvant chemotherapy, followed by poly adenosine diphosphate-ribose polymerase (PARP) inhibitors until disease progression or the end of the study. All patients will be closely monitored throughout the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125 and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.

Clinical Trial Description

This observational study is designed for exploring prognostic and predictive values of the tumor-informed bespoke ctDNA assay in advanced EOC. Newly diagnosed patients who are eligible for radical surgery or relapsed patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery will be enrolled. The patients will be treated with SOC adjuvant therapies followed by PARP inhibitor for maintenance. To evaluate ctDNA dynamics, tumor tissue collected from surgery will be sequenced with whole-exome sequencing (WES) to design patient-specific 16-plex panel. At planned monitoring timepoints, blood samples will be drawn, and ctDNA will be sequenced with ultra-deep ctDNA high-throughput sequencing methods. Traditional surveillance methods will be applied as comparison, including but not limited to carbohydrate antigen 125 (CA-125)/ human epididymal protein 4 (HE4)/ carcinoembryonic antigen (CEA)/ carbohydrate antigen 199 (CA199), etc., as well as standard imaging. Survival analyses will be conducted based on ctDNA status (positive/negative) after surgery. Recurrence rate of each subgroup, positive predictive values and negative predictive values etc. will be examined. Changes in ctDNA levels (ΔctDNA) during treatment will be used to evaluate the efficacy of maintenance therapy comparing traditional biomarkers, ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05446545
Study type Observational
Source Fudan University
Contact Hao Wen, MD
Phone +86-021-64175590
Email wenhao@shca.org.cn
Status Recruiting
Phase
Start date September 1, 2021
Completion date December 31, 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2