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Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04927611
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : September 24, 2021
D1 Medical Technology (Shanghai) Co., Ltd, China
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 16, 2021
Last Update Posted Date September 24, 2021
Actual Study Start Date June 6, 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2021)
  • Bioinformatics analysis of single-cell sequencing results [ Time Frame: Half a year ]
    Analysis of NEN Molecular Biology Information Using Single Cell Sequencing Technology
  • Model construction [ Time Frame: One year ]
    Collect fresh specimens of NEN to cultivate primary cell lines, construct organoids, and establish animal models of NEN
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 12, 2021)
  • Exploration of NEN organoid [ Time Frame: One year ]
    To explore and optimize the medium scheme of NEN orgnoid and methods of histomorphological identification of type organs
  • Tumor microenvironment [ Time Frame: One year ]
    The tumor microenvironment of NEN was analyzed
  • Comparison of mechanism of NEN with PDAC [ Time Frame: Half a year ]
    Collect fresh specimens of pancreatic ductal adenocarcinoma (PDAC) for single-cell sequencing and organoid construction for comparison with NEN
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm
Official Title Single-cell Sequencing and Establishment of Cell Lines, Organoids, and Transplanted Tumor Models in Neuroendocrine Neoplasm
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.
Detailed Description

Neuroendocrine neoplasm (NEN) generally refers to all tumors that originate from peptidergic neurons and neuroendocrine cells. It is a relatively rare tumor, ranging from indolent, slow-growing low-grade malignant tumors to obvious distant metastases. A series of malignant tumors. The most common place for neuroendocrine tumors is in the digestive system, and about two-thirds of neuroendocrine tumors occur in the gastrointestinal pancreas. However, with the change of people's living habits and the improvement of physical examination awareness, the incidence of neuroendocrine tumors increased from 1.09/100,000 in 1973 to 6.98/100,000 in 2012. The incidence has increased by 6 times compared with other tumors. , NENs increase more rapidly. The incidence of people over 65 years of age has increased by 8 times, and the incidence of people younger than 50 years of age has also increased by 3 times, and the incidence has been increasing year by year. It is worth noting that the average age of pancreatic neuroendocrine tumors is only 56.7-13.3 years old, showing a younger trend.

Because most neuroendocrine tumors lack specific manifestations, coupled with unique inert biological characteristics, clinicians often lack understanding, which can easily lead to misdiagnosis and treatment. Taking gastrointestinal pancreatic neuroendocrine tumors (GEP-NEN) as an example, due to the uneven diagnosis and treatment level, GEP-NEN patients may be diagnosed with a delay of up to 7 years. Because of this, as many as 40-95% of GEP-NEN patients have developed distant metastases at the time of diagnosis, and 65-95% of them have liver metastases. Liver metastasis is the most critical prognostic risk factor in GEP-NEN, and it has a decisive impact on the survival of patients. The 5-year survival rate of gastrointestinal neuroendocrine tumors with liver metastasis is 56%-83%, while the 5-year survival rate of pancreatic neuroendocrine tumors is only 48.8%, and the 10-year survival rate is only 30.2%. For limited-stage patients, even if radical surgical resection, up to 94% of cases will still have recurrence and metastasis within 5 years. For inoperable patients, although chemotherapy, targeted therapy, biological therapy and other methods can be used, the effect is still limited. Therefore, the systematic development of basic-clinical translational research on neuroendocrine tumors is very important and imminent.

Based on the above-mentioned problems, this project intends to conduct a systematic and in-depth study of neuroendocrine tumors: 1. Use single-cell sequencing technology to deeply study the molecular biological characteristics of NEN tumors, tumor heterogeneity and cell subtypes. 2. Construct NEN models, including primary cell lines, organoids, and mouse animal models. This study can establish a neuroendocrine tumor research system to find the molecular mechanism and potential intervention targets of NEN recurrence and metastasis, and provide clinicians with safe and effective treatment strategies, thereby improving the therapeutic effect of neuroendocrine tumors.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Neuroendocrine Neoplasm
Intervention Procedure: Biopsy, open or laparoscopic surgery
Collect NEN and PDAC biopsy or surgical fresh tissue to conduct single cell sequencing or model construction.
Study Groups/Cohorts
  • Gastroenteropancreatic neuroendocrine neoplasms
    Collect biopsy/surgical fresh tissue of gastroenteropancreatic neuroendocrine neoplasms.
    Intervention: Procedure: Biopsy, open or laparoscopic surgery
  • Pancreatic ductal adenocarcinoma
    Collect biopsy/surgical fresh tissue of pancreatic ductal adenocarcinoma.
    Intervention: Procedure: Biopsy, open or laparoscopic surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 12, 2021)
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with non-gastrointestinal pancreatic neuroendocrine tumors or pancreatic ductal adenocarcinoma confirmed pathologically;
  2. Suffer from other digestive system diseases, such as irritable bowel syndrome, inflammatory bowel disease;
  3. Those who have incomplete follow-up data or refuse to accept follow-up;
  4. Patients with other malignant tumors or hematological diseases; -
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Xianjun Yu, MD, PhD +86-13801669875
Listed Location Countries China
Removed Location Countries  
Administrative Information
NCT Number NCT04927611
Other Study ID Numbers CSPAC-NEN-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xian-Jun Yu, Fudan University
Study Sponsor Fudan University
Collaborators D1 Medical Technology (Shanghai) Co., Ltd, China
Principal Investigator: Xianjun Yu, MD, PhD Fudan University
PRS Account Fudan University
Verification Date September 2021