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

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310902
• Other study ID #: 2024KY022
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: March 2024
• Source: Fujian Medical University Union Hospital
• Contact: Yu Pan, M.D.
• Phone: +86 18900316399
• Email: yupan199002[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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