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1. Newly diagnosed patients with advanced EOC (ND-EOC) who are eligible for radical surgery.
2. Patients relapsed from platinum-based therapy (rEOC) who are eligible for secondary cytoreductive surgery.

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, or other anti-tumor angiogenesis drugs or immune checkpoint inhibitors

ND-EOC or platinum-sensitive rEOC

Hao Wen, MD

Hao Wen, Dr

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.

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,

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

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

Determine PFS in ctDNA positive versus ctDNA negative groups.

Determine OS in ctDNA positive versus ctDNA negative groups.

BGI Tianjin

Fudan University

Director of Gynecologic Oncology

Uterine Cervical Neoplasms

Cervical cancer patients who meet the inclusion criteria and are eligible for radical surgical resection. Collect surgical tumor tissue samples from the screening stage of patients in this queue, as well as peripheral blood samples (20 ml/time) from baseline, postoperative, postoperative radiotherapy and chemotherapy end nodes, consolidation treatment end nodes (some patients with this treatment), and multiple nodes during the 6-month follow-up stage. Perform ctDNA MRD testing in a timely manner separately

Cervical cancer patients who meet the inclusion criteria and are eligible for radical radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the screening phase, as well as peripheral blood samples (20 ml/time) from multiple nodes at baseline, mid-term of curative radiotherapy and chemotherapy, after curative radiotherapy and chemotherapy, after consolidation therapy (if any), and at 6 months/time during the follow-up phase. Perform ctDNA MRD testing in a timely manner separately

Jinhua Zhou

Songbing Qin

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.

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.

A total of 80 patients who meet the inclusion criteria and voluntarily sign informed consent forms are planned to be enrolled. According to the acceptable curative treatment measures of the patients, they are divided into two groups: the "operable treatment group (N=40)" and the "curative radiotherapy and chemotherapy treatment group (N=40)". Obtain tumor tissue samples from each enrolled patient (fresh tumor tissue samples (60 mg) or FFPE samples (10-15 pieces)

Collect peripheral blood samples of 20 ml/time from multiple treatment nodes of enrolled patients, a total of 7-8 times per person

The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer

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

Geneplus-Beijing Co. Ltd.

Digestive System Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasm, Residual

Neoplasms, Squamous Cell

Disease Attributes

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Neoplastic Processes

Esophageal Cancer

This project is focusing on who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. The exclusive MRD (Minimal residual disease) probe consists of an exclusive "molecular label" formulated according to the individual genome mutation profile and 21 critical tumor driver genes. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.

The goal of this project is to recruit 50 patients who have locally advanced esophageal squamous cell carcinoma and have undergone neoadjuvant and adjuvant therapy, followed by surgical resection. Initially, tumor tissues from all patients will undergo a more comprehensive NGS sequencing process (WESPlus) than whole-exome sequencing. This will provide a complete genomic mutation profile for each patient. Subsequently, a specific algorithm will be used to accurately select 20 mutation sites as the patient's unique "molecular label." Additionally, 21 critical driver genes related to tumors will be combined, leading to the creation of an exclusive MRD probe. This will enable ultra-high-depth capture sequencing of ctDNA samples from patients at 100,000x. By continuously monitoring each patient's ctDNA dynamics, changes in ctDNA concentration or ctDNA-MRD negative/positive results will serve as the primary indicators to assess the efficacy and prognosis of patients with esophageal squamous cell carcinoma.

Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.

Efficacy Evaluation and Recurrence Monitoring of Neoadjuvant Therapy and Adjuvant Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.

No residual tumor is the esophagus or dissected lymph nodes.

The time from date of diagnosis to the time of recurrence or death.

The time from date of diagnosis to the time of death.

Haplox

Guangdong Provincial People's Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bespoke ctDNA Assay for Recurrence and Treatment Response Monitoring in Advanced Epithelial Ovarian Cancer	NCT05446545	Ovarian Cancer	ND-EOC or plati...	18 Years - 70 Years	Fudan University
The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer	NCT06283875	Ovarian Cancer		18 Years - 80 Years	Geneplus-Beijing Co. Ltd.
Efficacy Evaluation and Recurrence Monitoring of Therapy for Esophageal Squamous Cell Carcinoma Based on ctDNA-MRD.	NCT05900583	Minimal Residua... Esophageal Squa...		18 Years - 80 Years	Guangdong Provincial People's Hospital
The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer	NCT06283875	Ovarian Cancer		18 Years - 80 Years	Geneplus-Beijing Co. Ltd.

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