Single-cell Sequencing Analysis of Resectable/Borderline Resectable Pancreatic Cancer Patients

March 12, 2024 updated by: Yu Pan, Fujian Medical University Union Hospital
Preoperative neoadjuvant chemotherapy is widely used in treating patients with borderline resectable pancreatic cancer (BRPC). However, there are limitations in this field. Treatment strategies and definitions for BRPC patients differ, and the efficacy and prognosis of neoadjuvant chemotherapy vary greatly.This study aims to utilize single-cell sequencing technology to investigate in-depth the composition and interactions of the tumor microenvironment in patients from the surgical-only group and the preoperative neoadjuvant chemotherapy group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Resectable/borderline resectable pancreatic cancer patients diagnosed based on pathological and preoperative imaging evaluation

Description

Inclusion Criteria:

  • 18 years ≤ age ≤ 75 years.
  • Resectable/borderline resectable pancreatic cancer patients diagnosed based on pathological and preoperative imaging evaluation.
  • No prior history of any form of anti-tumor treatment.
  • At least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG): 0-1.
  • Not participated in any other clinical studies before or during treatment.
  • Willingness to participate voluntarily in this study, signing an informed consent form.

Exclusion Criteria:

  • History of any other malignant tumor, except for completely resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, within the past 5 years.
  • Vaccination with live vaccines within 4 weeks prior to enrollment or during the study period.
  • Active autoimmune diseases or a history of autoimmune diseases within the past 4 weeks before enrollment.
  • Allogeneic bone marrow or organ transplantation.
  • Active gastric or duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors in the gastrointestinal tract, or other conditions determined by the investigator that may cause gastrointestinal bleeding or perforation.
  • Evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding >30 mL within 3 months, hematemesis, melena, or hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or occurrence of thromboembolic events within 12 months (including stroke events and/or transient ischemic attacks).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Borderline Resectable Pancreatic Cancer
Cancer tissue specimens can be collected postoperatively following neoadjuvant chemotherapy.
Diagnostic test: Single-cell Sequencing Analysis
Identification of rare cell populations, the characterization of cell types and subtypes, and the discovery of novel cell states.
Resectable Pancreatic Cancer
Cancer tissue specimens can be directly collected postoperatively
Diagnostic test: Single-cell Sequencing Analysis
Identification of rare cell populations, the characterization of cell types and subtypes, and the discovery of novel cell states.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioinformatics analysis of single-cell sequencing results
Time Frame: Collected during surgical treatment
Using single-cell sequencing technology, in-depth analysis of surgical samples from resectable/borderline resectable pancreatic cancer patients is conducted to investigate the composition and interactions of the tumor microenvironment in pancreatic cancer.
Collected during surgical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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