The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

Pancreatic Cancer Clinical Trial

— MAP-02  

Official title:

The Value of Molecular Residual Disease Monitoring Based on ctDNA in Resected Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802407
• Other study ID #: K3378-02
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2030

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Chunmei Bai, MD
• Phone: 010-69158764
• Email: tangh160706[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore the value of molecular residual disease (MRD) monitoring based on ctDNA in resected pancreatic cancer. The main questions it aims to answer are:

• prognostic value of baseline MRD;

• the role of MRD dynamic changes after treatment in guiding treatment. Peripheral blood derived from participants will be obtained for MRD test before adjuvant chemotherapy initiation and at the first imaging assessment after chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2030
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with pancreatic cancer who had undergone curative-intent surgery (R0 or R1 resection);

• both sexes, age =18 years old;

• ECOG performance status score =2;

• the expected survival time was =3 months.

Exclusion Criteria:

• a known diagnosis of pancreatic cancer other than ductal adenocarcinoma;

• treated with any systemic antitumor treatment before first-line chemotherapy onset;

• died or lost to follow-up within one month after the initiation of adjuvant chemotherpay;

• combined with other primary malignances.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Resectable Carcinoma

Intervention

Drug:
• Later-line therapy
Another chemotherapy regimen, targeted therapy, or immunotherapy

Locations

Country	Name	City	State
China	Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The prognostic value of MRD	The prognostic value of baseline MRD and dynamic MRD changes	Baseline until death from any cause (up to approximately 60 months)
Other	The prognostic role of targeted therapy selected based on MRD	The prognostic role of targeted therapy selected based on MRD	Baseline until death from any cause (up to approximately 60 months)
Primary	Disease-free survival	The date of adjuvant chemotherpay initiation to tumor recurrence, local-regional or distant metastases, or death due to any cause.	Baseline until death from any cause (up to approximately 36 months)
Secondary	Overall survival	The date of adjuvant chemotherpay initiation to death due to any cause.	Baseline until death from any cause (up to approximately 60 months)