Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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; -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04927611
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fudan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xianjun Yu, MD, PhD
Principal Investigator Affiliation Fudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroendocrine Neoplasm
Additional Details

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.

Arms & Interventions

Arms

: Gastroenteropancreatic neuroendocrine neoplasms

Collect biopsy/surgical fresh tissue of gastroenteropancreatic neuroendocrine neoplasms.

: Pancreatic ductal adenocarcinoma

Collect biopsy/surgical fresh tissue of pancreatic ductal adenocarcinoma.

Interventions

Procedure: - Biopsy, open or laparoscopic surgery

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

Contact a Trial Team

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International Sites

Shanghai, Shanghai, China

Status

Recruiting

Address

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

Shanghai, Shanghai, 200032

Site Contact

Xianjun Yu, M.D., Ph.D.

[email protected]

+86-21-6417-5590

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