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Recruiting NCT06310902

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

Observational Pancreatic Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Single-cell Sequencing Analysis.
Who it may be relevant to
Registry conditions: Pancreatic Neoplasms. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Bioinformatics analysis of single-cell sequencing results [Time frame: Collected during surgical treatment]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Publications

  • Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van PMID 35084987
  • Gonzalez-Silva L, Quevedo L, Varela I. Tumor Functional Heterogeneity Unraveled by scRNA-seq Technologies. Trends Cancer. 2020 Jan;6(1):13-19. doi: 10.1016/j.trecan.2019.11.010. Epub 2020 Jan 3. PMID 31952776
  • Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven PMID 32105518

Identifiers

NCT: NCT06310902 · 2024KY022

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗