Status:
UNKNOWN
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Weihe Medical Laboratory Co., Ltd.
Conditions:
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
40-75 years
Brief Summary
This trial aims to develop a minimal residual disease (MRD) detection model for predicting recurrence of patients with stage I-II pancreatic ductal adenocarcinoma after surgery and adjuvant therapy, b...
Detailed Description
The entire study is divided into two stages. Stage one is the enrollment period. 51 subjects with pancreatic ductal adenocarcinoma in stages I-II who have not received neoadjuvant therapy and have und...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic ductal adenocarcinoma;
- Aged ≥ 40 years and \< 75 years, both sexes;
- Patients receive radical resection with curative intent, followed by adjuvant therapy;
- Tumour size not less than 1 cm \* 1 cm \* 1 cm and be able to provide surgical tissue samples for molecular testing after pathological evaluation;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Negative margins (R0 or R1) by naked eye or no recurrence/metastasis detected on imaging after surgery or before adjuvant therapy, and CA 19-9\<37 U/ml;
- Patients understand and voluntarily sign the informed consent form and follow the sampling, assessment and visit requirements of this study.
- Exclusion criteria:
- Pregnant and lactating (by self-report);
- Any tumor history of malignancies;
- Positive cutting margins (R2);
- Received neoadjuvant therapy before surgery;
- Not be able to receive radical surgery;
- Organ transplantation history;
- Organ dysfunction (moderate or severe renal impairment with absolute centrocyte count \< 1.0 x 10\^9/L, platelet count \< 75 x 10\^9/L, haemoglobin \< 80 g/L, AST/ALT \> 2.5 times upper limit of normal);
- Other conditions deemed unsuitable for enrollment by the investigator.
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06151691
Start Date
December 1 2023
End Date
November 30 2025
Last Update
November 30 2023
Active Locations (1)
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1
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, China, 200032