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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
Sponsor:
Collaborator:
BGI Tianjin
Information provided by (Responsible Party):
Xiaohua Wu MD, Fudan University

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 through out the course of disease by a tumor-informed bespoke ctDNA assay as well as traditional methods of surveillance, such as CA125, HE4, CEA, CA199, and imaging. This study may provide preliminary evidence for ctDNA-guided treatment decisions in future clinical practice.

Condition or disease Intervention/treatment
Ovarian Cancer Drug: platinum-sensitive EOC Drug: platinum-resistant and rEOC

Detailed 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,

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Study Type : Observational
Estimated Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Group/Cohort Intervention/treatment
ND-EOC
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

platinum-sensitive rEOC
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




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Two years ]
    Determine PFS in ctDNA positive versus ctDNA negative groups.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Two years ]
    Determine OS in ctDNA positive versus ctDNA negative groups.


Biospecimen Retention:   Samples With DNA
Tumor tissue and peripheral blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-representation of gender identity
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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);
  2. Patients in pregnancy;
  3. Patients with a history of blood transfusion within 3 months before enrollment;
  4. Newly diagnosed patients who only received laparoscopic surgery;
  5. Patients received chemotherapy or other anti-tumor therapy before surgery.

Information from the National Library of Medicine

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


Contacts
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Contact: Hao Wen, MD +86-021-64175590 ext 81000 wenhao@shca.org.cn

Locations
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China, Shanghai
Hao Wen Recruiting
Shanghai, Shanghai, China, 200023
Contact: Hao Wen, Dr    +862164175590 ext 81000    wenhao@shca.org.cn   
Sponsors and Collaborators
Fudan University
BGI Tianjin
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Responsible Party: Xiaohua Wu MD, Director of Gynecologic Oncology, Fudan University
ClinicalTrials.gov Identifier: NCT05446545    
Other Study ID Numbers: 2021-39-2342
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaohua Wu MD, Fudan University:
Ovarian cancer
personalized ctDNA assay
treatment response monitoring
recurrence monitoring
PARPi
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type