Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm

NCT04927611 | Unknown DMC

• 1 other identifier: CSPAC-NEN-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to use single-cell sequencing technology to explore neuroendocrine neoplasm (NEN) molecular biological characteristics, tumor heterogeneity and cell subtypes. Besides. NEN models are constructed for basic research, including primary cell lines, organoids, and animal models.

Conditions

Neuroendocrine Neoplasm

Keywords

Neuroendocrine Neoplasm; Single Cell Sequencing Technology; Primary Cell Culture; Organoid; Patient-derived Tumor Xenograft

Outcome Measures

Primary Outcomes (2)

• Bioinformatics analysis of single-cell sequencing results

  Analysis of NEN Molecular Biology Information Using Single Cell Sequencing Technology

  Half a year

• Model construction

  Collect fresh specimens of NEN to cultivate primary cell lines, construct organoids, and establish animal models of NEN

  One year

Secondary Outcomes (3)

• Exploration of NEN organoid

  One year

• Tumor microenvironment

  One year

• Comparison of mechanism of NEN with PDAC

  Half a year

Study Arms (2)

Gastroenteropancreatic neuroendocrine neoplasms

Collect biopsy/surgical fresh tissue of gastroenteropancreatic neuroendocrine neoplasms.

Procedure: Biopsy, open or laparoscopic surgery

Pancreatic ductal adenocarcinoma

Collect biopsy/surgical fresh tissue of pancreatic ductal adenocarcinoma.

Procedure: Biopsy, open or laparoscopic surgery

Interventions

Biopsy, open or laparoscopic surgery PROCEDURE

Collect NEN and PDAC biopsy or surgical fresh tissue to conduct single cell sequencing or model construction.

Gastroenteropancreatic neuroendocrine neoplasms; Pancreatic ductal adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Collect specimens confirmed to be NEN or PDAC by surgery or biopsy histopathology for single-cell sequencing analysis and the construction of primary cells, organoids and animal models.

You may qualify if:

• Between the ages of 18 and 80, with any gender;
• Physical fitness score ECOG 0～1 points;
• The diagnosis is considered as gastrointestinal pancreatic neuroendocrine tumor or pancreatic ductal adenocarcinoma;
• There is no obvious contraindication to surgery or biopsy;
• Uncompensated liver cirrhosis, acute and chronic hepatitis and other diseases;
• No history of other biliary tract related diseases;
• Volunteer to participate and sign the informed consent form. -

You may not qualify if:

• Patients with non-gastrointestinal pancreatic neuroendocrine tumors or pancreatic ductal adenocarcinoma confirmed pathologically;
• Suffer from other digestive system diseases, such as irritable bowel syndrome, inflammatory bowel disease;
• Those who have incomplete follow-up data or refuse to accept follow-up;
• Patients with other malignant tumors or hematological diseases; -

Sponsors & Collaborators

• Fudan University: lead
• D1 Medical Technology (Shanghai) Co., Ltd, China: collaborator

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Biopsy; Laparoscopy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Xianjun Yu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianjun Yu, MD, PhD

CONTACT

+86-13801669875; yuxianjun@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Shanghai Pancreatic Cancer Institute

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: June 6, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)