Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach

NCT06151691 | Unknown

• 1 other identifier: PC-MRD
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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, based on cfDNA fragmentation and methylation signal.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 1.5-year disease-free survival

  1.5-year disease-free survival of patients with pancreatic ductal adenocarcinoma receiving post-operative adjuvant chemotherapy.

  18 months

Secondary Outcomes (4)

• Sensitivity of the multi-omics prognostic model

  18 months

• Specificity of the multi-omics prognostic model

  18 months

• Area under the receiver operating characteristic curve (AUROC) of the multi-omics prognostic model

  18 months

• Sensitivity of the multi-omics prognostic model in different subgroups

  18 months

Study Arms (1)

Case-Cancer arm

Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test

Other: Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test

Interventions

Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test OTHER

Blood samples of participants meet the inclusion/exclusion criteria will be collected. Pancreatic ductal adenocarcinoma minimal residual disease detection test.

Case-Cancer arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from clinic and medical centers. Participants are defined as new diagnosis cancer patients with pancreatic ductal adenocarcinoma. Demographic and cancer risk-related characteristics (eg, age, gender, smoking status, diabetes) will be collected from all enrolled subjects.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Weihe Medical Laboratory Co., Ltd.: collaborator

Study Sites (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, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

cfDNA and tumor tissue DNA

Central Study Contacts

Xian-Jun Yu, M.D., Ph.D.

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

Si Shi, M.D., Ph.D.

CONTACT

+86 21 64175590

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: November 30, 2023
• Study Start: December 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)