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Trial Title:
Assessment of Early Pancreatic Cancer Prognosis by Minimal Residual Disease Using Multi-omics Approach
NCT ID:
NCT06151691
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Neoplasm, Residual
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Blood collection and Pancreatic ductal adenocarcinoma minimal residual disease detection test
Description:
Blood samples of participants meet the inclusion/exclusion criteria will be collected.
Pancreatic ductal adenocarcinoma minimal residual disease detection test.
Arm group label:
Case-Cancer arm
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.
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 undergone radical surgery were enrolled. Blood samples at
the time point before surgical treatment (T0) were collected and fresh tissue specimens
(cancerous tissue and adjacent normal tissue) were collected. Blood samples were
subjected to methylation, fragment group, and CNV multi-omics testing, and tissue samples
were subjected to target methylation area testing. Stage two is the follow-up period.
Blood samples from the fifth week after surgery to before adjuvant therapy (T1) and blood
samples from 4-8 weeks after adjuvant therapy (T2) were collected. Blood samples were
subjected to methylation, fragment group, and CNV multi-omics testing with different
techniques. The subjects were followed up for 1.5 years. According to progression and
recurrence, the subjects were divided into progression group and non-progression group.
Methylation and multi-omics prognosis models were trained and compared for their
performance in residual detection and recurrence prediction.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
1. Patients with clinically and/or pathologically diagnosis of stage I/II pancreatic
ductal adenocarcinoma;
2. Aged ≥ 40 years and < 75 years, both sexes;
3. Patients receive radical resection with curative intent, followed by adjuvant
therapy;
4. 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;
5. Eastern Cooperative Oncology Group (ECOG) score of 0-2;
6. 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;
7. Patients understand and voluntarily sign the informed consent form and follow the
sampling, assessment and visit requirements of this study.
Exclusion criteria:
1. Pregnant and lactating (by self-report);
2. Any tumor history of malignancies;
3. Positive cutting margins (R2);
4. Received neoadjuvant therapy before surgery;
5. Not be able to receive radical surgery;
6. Organ transplantation history;
7. 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);
8. Other conditions deemed unsuitable for enrollment by the investigator.
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
December 1, 2023
Completion date:
November 30, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Weihe Medical Laboratory Co., Ltd.
Agency class:
Industry
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06151691
