Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer (EOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05446545|
Recruitment Status : Recruiting
First Posted : July 6, 2022
Last Update Posted : July 6, 2022
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Drug: platinum-sensitive EOC Drug: platinum-resistant and rEOC|
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 Type :||Observational|
|Estimated Enrollment :||139 participants|
|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|
|Actual Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Newly diagnosed patients with advanced EOC who are eligible for radical surgery.
Drug: platinum-sensitive EOC
For platinum-sensitive patients: platinum-based combined chemotherapy or bevacizumab will be used for adjuvant treatment, followed by maintenance therapy with poly adenosine diphosphate-ribose polymerase (PARP) inhibitor or bevacizumab
Patients relapsed from platinum-based therapy who are eligible for secondary cytoreductive surgery.
Drug: platinum-resistant and rEOC
For platinum-resistant patients or refractory relapsed patients: non-platinum single-drug chemotherapy or combined anti-angiogenic targeted chemotherapy
- Progression free survival (PFS) [ Time Frame: Two years ]Determine PFS in ctDNA positive versus ctDNA negative groups.
- Overall Survival (OS) [ Time Frame: Two years ]Determine OS in ctDNA positive versus ctDNA negative groups.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05446545
|Contact: Hao Wen, MD||+86-021-64175590 ext email@example.com|
|Shanghai, Shanghai, China, 200023|
|Contact: Hao Wen, Dr +862164175590 ext 81000 firstname.lastname@example.org|