Neuroendocrine NeoplasmNCT04927611
Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm
An observational study of Neuroendocrine Neoplasm, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Neoplasm
- What is being tested?
- Biopsy, open or laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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. -
Who cannot join
- 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; -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, M.D., Ph.D., +86-21-6417-5590, yuxianjun@fudanpci.org
Xianjun Yu, M.D., Ph.D.
About this study
Official title: Single-cell Sequencing and Establishment of Cell Lines, Organoids, and Transplanted Tumor Models in Neuroendocrine Neoplasm
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.
Read the 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.
- Conditions
- Neuroendocrine Neoplasm
- Being tested
- Biopsy, open or laparoscopic surgery
- Keywords
- Neuroendocrine Neoplasm, Single Cell Sequencing Technology, Primary Cell Culture, Organoid, Patient-derived Tumor Xenograft
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy, open or laparoscopic surgeryProcedure or surgery
Collect NEN and PDAC biopsy or surgical fresh tissue to conduct single cell sequencing or model construction.
| Study group | Role | What they receive |
|---|---|---|
| Gastroenteropancreatic neuroendocrine neoplasms | Collect biopsy/surgical fresh tissue of gastroenteropancreatic neuroendocrine neoplasms. Receives: Procedure: Biopsy, open or laparoscopic surgery | |
| Pancreatic ductal adenocarcinoma | Collect biopsy/surgical fresh tissue of pancreatic ductal adenocarcinoma. Receives: Procedure: Biopsy, open or laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioinformatics analysis of single-cell sequencing results
Analysis of NEN Molecular Biology Information Using Single Cell Sequencing Technology
Measured: Half a year
Model construction
Collect fresh specimens of NEN to cultivate primary cell lines, construct organoids, and establish animal models of NEN
Measured: One year
Secondary outcomes (3)
Exploration of NEN organoid
To explore and optimize the medium scheme of NEN orgnoid and methods of histomorphological identification of type organs
Measured: One year
Tumor microenvironment
The tumor microenvironment of NEN was analyzed
Measured: One year
Comparison of mechanism of NEN with PDAC
Collect fresh specimens of pancreatic ductal adenocarcinoma (PDAC) for single-cell sequencing and organoid construction for comparison with NEN
Measured: Half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start6 Jun 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- D1 Medical Technology (Shanghai) Co., Ltd, China
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Xianjun Yu, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927611
- Sponsor's protocol ID
- CSPAC-NEN-1
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.
PubMed 18565894Modlin IM, Kidd M, Latich I, Zikusoka MN, Shapiro MD. Current status of gastrointestinal carcinoids. Gastroenterology. 2005 May;128(6):1717-51. doi: 10.1053/j.gastro.2005.03.038.
PubMed 15887161Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
PubMed 28448665Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 13.
PubMed 25312765Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2.
PubMed 18177818Saxena A, Chua TC, Sarkar A, Chu F, Liauw W, Zhao J, Morris DL. Progression and survival results after radical hepatic metastasectomy of indolent advanced neuroendocrine neoplasms (NENs) supports an aggressive surgical approach. Surgery. 2011 Feb;149(2):209-20. doi: 10.1016/j.surg.2010.06.008. Epub 2010 Aug 2.
PubMed 20674950Pape UF, Berndt U, Muller-Nordhorn J, Bohmig M, Roll S, Koch M, Willich SN, Wiedenmann B. Prognostic factors of long-term outcome in gastroenteropancreatic neuroendocrine tumours. Endocr Relat Cancer. 2008 Dec;15(4):1083-97. doi: 10.1677/ERC-08-0017. Epub 2008 Jul 4.
PubMed 18603570Pavel M, Baudin E, Couvelard A, Krenning E, Oberg K, Steinmuller T, Anlauf M, Wiedenmann B, Salazar R; Barcelona Consensus Conference participants. ENETS Consensus Guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012;95(2):157-76. doi: 10.1159/000335597. Epub 2012 Feb 15. No abstract available.
PubMed 22262022Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
PubMed 24384494Hanahan D, Coussens LM. Accessories to the crime: functions of cells recruited to the tumor microenvironment. Cancer Cell. 2012 Mar 20;21(3):309-22. doi: 10.1016/j.ccr.2012.02.022.
PubMed 22439926Baryawno N, Przybylski D, Kowalczyk MS, Kfoury Y, Severe N, Gustafsson K, Kokkaliaris KD, Mercier F, Tabaka M, Hofree M, Dionne D, Papazian A, Lee D, Ashenberg O, Subramanian A, Vaishnav ED, Rozenblatt-Rosen O, Regev A, Scadden DT. A Cellular Taxonomy of the Bone Marrow Stroma in Homeostasis and Leukemia. Cell. 2019 Jun 13;177(7):1915-1932.e16. doi: 10.1016/j.cell.2019.04.040. Epub 2019 May 23.
PubMed 31130381Ren X, Kang B, Zhang Z. Understanding tumor ecosystems by single-cell sequencing: promises and limitations. Genome Biol. 2018 Dec 3;19(1):211. doi: 10.1186/s13059-018-1593-z.
PubMed 30509292Heath JR, Ribas A, Mischel PS. Single-cell analysis tools for drug discovery and development. Nat Rev Drug Discov. 2016 Mar;15(3):204-16. doi: 10.1038/nrd.2015.16. Epub 2015 Dec 16.
PubMed 26669673Lytle NK, Ferguson LP, Rajbhandari N, Gilroy K, Fox RG, Deshpande A, Schurch CM, Hamilton M, Robertson N, Lin W, Noel P, Wartenberg M, Zlobec I, Eichmann M, Galvan JA, Karamitopoulou E, Gilderman T, Esparza LA, Shima Y, Spahn P, French R, Lewis NE, Fisch KM, Sasik R, Rosenthal SB, Kritzik M, Von Hoff D, Han H, Ideker T, Deshpande AJ, Lowy AM, Adams PD, Reya T. A Multiscale Map of the Stem Cell State in Pancreatic Adenocarcinoma. Cell. 2019 Apr 18;177(3):572-586.e22. doi: 10.1016/j.cell.2019.03.010. Epub 2019 Apr 4.
PubMed 30955884Kumar MP, Du J, Lagoudas G, Jiao Y, Sawyer A, Drummond DC, Lauffenburger DA, Raue A. Analysis of Single-Cell RNA-Seq Identifies Cell-Cell Communication Associated with Tumor Characteristics. Cell Rep. 2018 Nov 6;25(6):1458-1468.e4. doi: 10.1016/j.celrep.2018.10.047.
PubMed 30404002
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-cell Sequencing and Establishment of Cell Lines, Organoids, and Transplanted Tumor Models in Neuroendocrine Neoplasm
- ClinicalTrials.gov ID
- NCT04927611
- Acronym / sponsor ID
- CSPAC-NEN-1
- Conditions
- Neuroendocrine Neoplasm
- Keywords
- Neuroendocrine Neoplasm, Single Cell Sequencing Technology, Primary Cell Culture, Organoid, Patient-derived Tumor Xenograft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- D1 Medical Technology (Shanghai) Co., Ltd, China
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroenteropancreatic neuroendocrine neoplasms | – | Procedure: Biopsy, open or laparoscopic surgeryCollect biopsy/surgical fresh tissue of gastroenteropancreatic neuroendocrine neoplasms. |
| Pancreatic ductal adenocarcinoma | – | Procedure: Biopsy, open or laparoscopic surgeryCollect biopsy/surgical fresh tissue of pancreatic ductal adenocarcinoma. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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; -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy, open or laparoscopic surgeryCollect NEN and PDAC biopsy or surgical fresh tissue to conduct single cell sequencing or model construction. | Procedure or surgery | Gastroenteropancreatic neuroendocrine neoplasms, Pancreatic ductal adenocarcinoma |
Primary outcome
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
3 secondary outcomes
Exploration of NEN organoid
Time frame: One year
Tumor microenvironment
Time frame: One year
Comparison of mechanism of NEN with PDAC
Time frame: Half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Background: PubMed 18565894Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.
- Background: PubMed 15887161Modlin IM, Kidd M, Latich I, Zikusoka MN, Shapiro MD. Current status of gastrointestinal carcinoids. Gastroenterology. 2005 May;128(6):1717-51. doi: 10.1053/j.gastro.2005.03.038.
- Background: PubMed 28448665Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589.
- Background: PubMed 25312765Hallet J, Law CH, Cukier M, Saskin R, Liu N, Singh S. Exploring the rising incidence of neuroendocrine tumors: a population-based analysis of epidemiology, metastatic presentation, and outcomes. Cancer. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 13.
- Background: PubMed 18177818Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2.
- Background: PubMed 20674950Saxena A, Chua TC, Sarkar A, Chu F, Liauw W, Zhao J, Morris DL. Progression and survival results after radical hepatic metastasectomy of indolent advanced neuroendocrine neoplasms (NENs) supports an aggressive surgical approach. Surgery. 2011 Feb;149(2):209-20. doi: 10.1016/j.surg.2010.06.008. Epub 2010 Aug 2.
- Background: PubMed 18603570Pape UF, Berndt U, Muller-Nordhorn J, Bohmig M, Roll S, Koch M, Willich SN, Wiedenmann B. Prognostic factors of long-term outcome in gastroenteropancreatic neuroendocrine tumours. Endocr Relat Cancer. 2008 Dec;15(4):1083-97. doi: 10.1677/ERC-08-0017. Epub 2008 Jul 4.
- Background: PubMed 22262022Pavel M, Baudin E, Couvelard A, Krenning E, Oberg K, Steinmuller T, Anlauf M, Wiedenmann B, Salazar R; Barcelona Consensus Conference participants. ENETS Consensus Guidelines for the management of patients with liver and other distant metastases from neuroendocrine neoplasms of foregut, midgut, hindgut, and unknown primary. Neuroendocrinology. 2012;95(2):157-76. doi: 10.1159/000335597. Epub 2012 Feb 15. No abstract available.
- Background: PubMed 24384494Frilling A, Modlin IM, Kidd M, Russell C, Breitenstein S, Salem R, Kwekkeboom D, Lau WY, Klersy C, Vilgrain V, Davidson B, Siegler M, Caplin M, Solcia E, Schilsky R; Working Group on Neuroendocrine Liver Metastases. Recommendations for management of patients with neuroendocrine liver metastases. Lancet Oncol. 2014 Jan;15(1):e8-21. doi: 10.1016/S1470-2045(13)70362-0.
- Background: PubMed 22439926Hanahan D, Coussens LM. Accessories to the crime: functions of cells recruited to the tumor microenvironment. Cancer Cell. 2012 Mar 20;21(3):309-22. doi: 10.1016/j.ccr.2012.02.022.
- Background: PubMed 31130381Baryawno N, Przybylski D, Kowalczyk MS, Kfoury Y, Severe N, Gustafsson K, Kokkaliaris KD, Mercier F, Tabaka M, Hofree M, Dionne D, Papazian A, Lee D, Ashenberg O, Subramanian A, Vaishnav ED, Rozenblatt-Rosen O, Regev A, Scadden DT. A Cellular Taxonomy of the Bone Marrow Stroma in Homeostasis and Leukemia. Cell. 2019 Jun 13;177(7):1915-1932.e16. doi: 10.1016/j.cell.2019.04.040. Epub 2019 May 23.
- Background: PubMed 30509292Ren X, Kang B, Zhang Z. Understanding tumor ecosystems by single-cell sequencing: promises and limitations. Genome Biol. 2018 Dec 3;19(1):211. doi: 10.1186/s13059-018-1593-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianjun Yu, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Neoplasm, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, MD, PhD (+86-13801669875, yuxianjun@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioinformatics analysis of single-cell sequencing results (time frame: Half a year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04927611, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.