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RecruitingNCT06310902Updated Mar 15, 2024

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

An observational study in Pancreatic Neoplasms, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Fujian Medical University Union Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Pancreatic neoplasms
  • Single-cell sequencing
  • Immune microenvironment
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Borderline Resectable Pancreatic Cancer

    Cancer tissue specimens can be collected postoperatively following neoadjuvant chemotherapy.

    Diagnostic Test: Single-cell Sequencing Analysis

  • Resectable Pancreatic Cancer

    Cancer tissue specimens can be directly collected postoperatively

    Diagnostic Test: Single-cell Sequencing Analysis

Interventions

  • Diagnostic testSingle-cell Sequencing Analysis

    Identification of rare cell populations, the characterization of cell types and subtypes, and the discovery of novel cell states.

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What researchers measure

Primary outcomes

  1. Bioinformatics analysis of single-cell sequencing results

    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.

    Time frame: Collected during surgical treatment

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
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References and documents

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 Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. doi: 10.1200/JCO.21.02233. Epub 2022 Jan 27. PubMed 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. Erratum In: Trends Cancer. 2021 Mar;7(3):265. doi: 10.1016/j.trecan.2021.02.001. PubMed 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 G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. doi: 10.1200/JCO.19.02274. Epub 2020 Feb 27. PubMed 32105518 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06310902
Lead sponsor
Fujian Medical University Union Hospital
Responsible party
Yu Pan (Principal Investigator, Fujian Medical University Union Hospital) — Principal investigator
First posted
Mar 15, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Mar 15, 2024

Study contacts

Yu Pan, M.D.
Contact
yupan199002@163.com
+86 18900316399

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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