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

NCT06310902 | Recruiting DMC

• 1 other identifier: 2024KY022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic neoplasms; Single-cell sequencing; Immune microenvironment

Outcome Measures

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.

  Collected during surgical treatment

Study Arms (2)

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

Single-cell Sequencing Analysis DIAGNOSTIC_TEST

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

Borderline Resectable Pancreatic Cancer; Resectable Pancreatic Cancer

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 35084987 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32105518 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue, paracancerous tissue, blood, and lymphonodu

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yu Pan, M.D.

CONTACT

+86 18900316399; yupan199002@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)