NCT04931446

Brief Summary

This project intends to analyze the molecular biological characteristics of NEN based on multi-omics, develop an exclusive NEN multi-omics big data platform, and carry out molecular subtypes and potential targets prediction, so as to improve the therapeutic effect of neuroendocrine tumors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

June 2, 2021

Last Update Submit

June 12, 2021

Conditions

Keywords

Neuroendocrine NeoplasmMulti-omics AnalysisMolecular Subtypes

Outcome Measures

Primary Outcomes (1)

  • NEN mechanism analysis based on Multi-omics

    Collect NEN tissue specimens and peripheral blood specimens for genomics, transcriptomics, proteomics, phosphorylation, metabolomics and other multiple omics sequencing analysis, so as to find the relationship between these molecular omics and phenotypes, explore NEN mechanism, including driver genes, activation of signal pathways, etc., and screen sensitive drugs based on potential targets. Use multi-omics data to establish NEN big data analysis platform, including sensitive target prediction, related gene prediction, survival analysis, and so on.

    One year

Secondary Outcomes (1)

  • NEN immune microenvironment analysis

    One year

Study Arms (1)

Gastroenteropancreatic neuroendocrine neoplasms

Procedure: Biopsy/surgical tissue and peripheral blood

Interventions

Retrieve specimens stored in the tissue bank, the main types of samples are RNAlater specimens, liquid nitrogen frozen specimens and peripheral blood specimens

Gastroenteropancreatic neuroendocrine neoplasms

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collect gastrointestinal pancreatic neuroendocrine tumor samples stored in the tissue bank of Fudan University Affiliated Tumor Hospital from January 31, 2010 to March 31, 2021

You may qualify if:

  • Received surgical treatment at Fudan University Affiliated Cancer Hospital from January 2010 to January 2021;
  • Postoperative pathology proved to be neuroendocrine tumor;
  • Has signed an informed consent form for tissue bank sample collection, agreeing to use the specimens and related clinical data for scientific research.

You may not qualify if:

  • Merge other malignant tumors;
  • The clinical data is missing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (12)

  • Alizadeh AA, Aranda V, Bardelli A, Blanpain C, Bock C, Borowski C, Caldas C, Califano A, Doherty M, Elsner M, Esteller M, Fitzgerald R, Korbel JO, Lichter P, Mason CE, Navin N, Pe'er D, Polyak K, Roberts CW, Siu L, Snyder A, Stower H, Swanton C, Verhaak RG, Zenklusen JC, Zuber J, Zucman-Rossi J. Toward understanding and exploiting tumor heterogeneity. Nat Med. 2015 Aug;21(8):846-53. doi: 10.1038/nm.3915.

    PMID: 26248267BACKGROUND
  • Hausser J, Alon U. Tumour heterogeneity and the evolutionary trade-offs of cancer. Nat Rev Cancer. 2020 Apr;20(4):247-257. doi: 10.1038/s41568-020-0241-6. Epub 2020 Feb 24.

    PMID: 32094544BACKGROUND
  • Cancer Genome Atlas Network. Comprehensive molecular characterization of human colon and rectal cancer. Nature. 2012 Jul 18;487(7407):330-7. doi: 10.1038/nature11252.

    PMID: 22810696BACKGROUND
  • Lehmann BD, Jovanovic B, Chen X, Estrada MV, Johnson KN, Shyr Y, Moses HL, Sanders ME, Pietenpol JA. Refinement of Triple-Negative Breast Cancer Molecular Subtypes: Implications for Neoadjuvant Chemotherapy Selection. PLoS One. 2016 Jun 16;11(6):e0157368. doi: 10.1371/journal.pone.0157368. eCollection 2016.

    PMID: 27310713BACKGROUND
  • Halaburkova A, Cahais V, Novoloaca A, Araujo MGDS, Khoueiry R, Ghantous A, Herceg Z. Pan-cancer multi-omics analysis and orthogonal experimental assessment of epigenetic driver genes. Genome Res. 2020 Oct;30(10):1517-1532. doi: 10.1101/gr.268292.120. Epub 2020 Sep 22.

    PMID: 32963031BACKGROUND
  • Taber A, Christensen E, Lamy P, Nordentoft I, Prip F, Lindskrog SV, Birkenkamp-Demtroder K, Okholm TLH, Knudsen M, Pedersen JS, Steiniche T, Agerbaek M, Jensen JB, Dyrskjot L. Molecular correlates of cisplatin-based chemotherapy response in muscle invasive bladder cancer by integrated multi-omics analysis. Nat Commun. 2020 Sep 25;11(1):4858. doi: 10.1038/s41467-020-18640-0.

    PMID: 32978382BACKGROUND
  • Sailem HZ, Bakal C. Identification of clinically predictive metagenes that encode components of a network coupling cell shape to transcription by image-omics. Genome Res. 2017 Feb;27(2):196-207. doi: 10.1101/gr.202028.115. Epub 2016 Nov 18.

    PMID: 27864353BACKGROUND
  • Su H, Shen Y, Xing F, Qi X, Hirshfield KM, Yang L, Foran DJ. Robust automatic breast cancer staging using a combination of functional genomics and image-omics. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7226-9. doi: 10.1109/EMBC.2015.7320059.

    PMID: 26737959BACKGROUND
  • Frilling 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.

    PMID: 24384494BACKGROUND
  • Mayo SC, de Jong MC, Pulitano C, Clary BM, Reddy SK, Gamblin TC, Celinksi SA, Kooby DA, Staley CA, Stokes JB, Chu CK, Ferrero A, Schulick RD, Choti MA, Mentha G, Strub J, Bauer TW, Adams RB, Aldrighetti L, Capussotti L, Pawlik TM. Surgical management of hepatic neuroendocrine tumor metastasis: results from an international multi-institutional analysis. Ann Surg Oncol. 2010 Dec;17(12):3129-36. doi: 10.1245/s10434-010-1154-5. Epub 2010 Jun 29.

    PMID: 20585879BACKGROUND
  • Pavel 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.

    PMID: 22262022BACKGROUND
  • Rindi G, D'Adda T, Froio E, Fellegara G, Bordi C. Prognostic factors in gastrointestinal endocrine tumors. Endocr Pathol. 2007 Fall;18(3):145-9. doi: 10.1007/s12022-007-0020-x.

    PMID: 18058263BACKGROUND

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xianjun Yu, MD, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianjun Yu, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
President of Shanghai Pancreatic Cancer Institute

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 18, 2021

Study Start

July 1, 2021

Primary Completion

March 1, 2022

Study Completion

December 1, 2022

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations