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

NCT05446545 | Recruiting

• 1 other identifier: 2021-39-2342
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Ovarian cancer; personalized ctDNA assay; treatment response monitoring; recurrence monitoring; PARPi

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Determine PFS in ctDNA positive versus ctDNA negative groups.

  Two years

Secondary Outcomes (1)

• Overall Survival (OS)

  Two years

Study Arms (1)

ND-EOC or platinum-sensitive rEOC

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.

Other: ND-EOC or platinum-sensitive rEOC

Interventions

ND-EOC or platinum-sensitive rEOC OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed advanced EOC patients who are eligible for radical surgery or relapsed EOC patients from platinum-based adjuvant chemotherapy who are eligible for secondary cytoreductive surgery.

You may qualify if:

• Female, over 18 years of age;
• Patients with advanced epithelial ovarian cancer who are eligible for radical surgery;
• Patients with advanced epithelial ovarian cancer relapsed from platinum-based therapies and eligible for secondary cytoreductive surgery;
• The subjects agree to sign the informed consent and agree to use their samples and data for related scientific research;
• Subjects agree to collect tissue samples and peripheral blood samples for whole exon sequencing and ctDNA monitoring.

You may not qualify if:

• Patients who are diagnosed, tested or treated for cancer other than ovarian cancer within 2 years (except for basal skin or squamous cell cancer that has been definitively treated);
• Patients in pregnancy;
• Patients with a history of blood transfusion within 3 months before enrollment;
• Newly diagnosed patients who only received laparoscopic surgery;
• Patients received chemotherapy or other anti-tumor therapy before surgery.

Sponsors & Collaborators

• Fudan University: lead
• BGI Tianjin: collaborator

Study Sites (1)

Hao Wen

Shanghai, Shanghai Municipality, 200023, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and peripheral blood

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Hao Wen, MD

CONTACT

+86-021-64175590; wenhao@shca.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecologic Oncology

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: July 6, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 28, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)