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

Study Overview

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

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.

N/A

Pancreatic Neoplasms

DIAGNOSTIC_TEST: Single-cell Sequencing Analysis

2024KY022

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-03-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-03-12
First Submitted that Met QC Criteria 2024-03-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-03-15
First Posted (ACTUAL) 2024-03-15	Results First Posted N/A	Last Verified 2024-03

Study Plan

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

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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.

Participant Group/Arm

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.

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

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

Name: Yu Pan, M.D.

Phone Number: +86 18900316399

Email: yupan199002@163.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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).

Collaborators and Investigators

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

Publications

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

General 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.
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.
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.

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