NCT05209061

Brief Summary

The overall purpose of this study is to describe the cellular composition of the human appendix and its gene expression using scRNAseq and scATACseq methods. This will potentially provide is with a complete and detailed map of the appendix´ immunological properties and its role in neuro-endocrine/metabolic functions. Our results will be held up against current knowledge of the appendix and its role in the human body and thus hopefully expand our understanding of this organ and the consequences of its removal by appendectomy.

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
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

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

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 12, 2022

Last Update Submit

February 6, 2023

Conditions

DiabetesAppendicitisInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

  • Profiling of open chromatin regions

    Mapping of cell types, including rare cell types, using profiling of open chromatin regions. (ATAC-seq) in biopsies from the appendix

    2 years

  • Evaluation of metabolic profile

    Using bioimpedance, insulin and glucose measurements and CHiP-seq we will determine patient phenotype and epigenetics to evaluate their metabolic risk-profile and correlate this to cell types in the appendix

    2 years

Secondary Outcomes (1)

  • Appendix biofilm

    2 years

Study Arms (1)

Colo-rectal cancer patients

Patients receiving right colectomy or ileo-ceacal resection for colorectal cancer

Other: Biopsy

Interventions

BiopsyOTHER

Participants included in the study, will have a full thickness biopsy of the middle of the appendix taken, after the resected bowel has been removed during surgery.

Colo-rectal cancer patients

Eligibility Criteria

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

Patients with verified colorectal-cancer, who have been scheduled for right colectomy or ileo-ceacal resection.

You may qualify if:

  • Patients undergoing a right or extended right-hemicolectomy for colon cancer
  • Patients able to read and understand danish
  • Patients able to give informed consent
  • Patients of Scandinavian ethnicity

You may not qualify if:

  • Previous large bowel resections
  • Suspicion pre or intraoperatively of disease in the appendix
  • Tumour \<10cm from the appendiceal orifice.
  • Known inflammatory bowel disease
  • Immuno-modulation treatment
  • Neo-adjuvant chemotherapy.
  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2720, Denmark

RECRUITING

Related Publications (8)

  • Kooij IA, Sahami S, Meijer SL, Buskens CJ, Te Velde AA. The immunology of the vermiform appendix: a review of the literature. Clin Exp Immunol. 2016 Oct;186(1):1-9. doi: 10.1111/cei.12821. Epub 2016 Jul 19.

    PMID: 27271818BACKGROUND

  • Somekh E, Serour F, Gorenstein A, Vohl M, Lehman D. Phenotypic pattern of B cells in the appendix: reduced intensity of CD19 expression. Immunobiology. 2000 Jan;201(3-4):461-9. doi: 10.1016/S0171-2985(00)80098-4.

    PMID: 10776800BACKGROUND

  • Spencer J, Finn T, Isaacson PG. Gut associated lymphoid tissue: a morphological and immunocytochemical study of the human appendix. Gut. 1985 Jul;26(7):672-9. doi: 10.1136/gut.26.7.672.

    PMID: 3874811BACKGROUND

  • Wei PL, Tsai MC, Hung SH, Lee HC, Lin HC, Lee CZ. Risk of new-onset type II diabetes after appendicectomy. Br J Surg. 2015 Sep;102(10):1267-71. doi: 10.1002/bjs.9875. Epub 2015 Jun 29.

    PMID: 26122401BACKGROUND

  • Sahami S, Wildenberg ME, Koens L, Doherty G, Martin S, D'Haens GRAM, Cullen G, Bemelman WA, Winter D, Buskens CJ. Appendectomy for Therapy-Refractory Ulcerative Colitis Results in Pathological Improvement of Colonic Inflammation: Short-Term Results of the PASSION Study. J Crohns Colitis. 2019 Feb 1;13(2):165-171. doi: 10.1093/ecco-jcc/jjy127.

    PMID: 30285094BACKGROUND

  • Buenrostro JD, Wu B, Chang HY, Greenleaf WJ. ATAC-seq: A Method for Assaying Chromatin Accessibility Genome-Wide. Curr Protoc Mol Biol. 2015 Jan 5;109:21.29.1-21.29.9. doi: 10.1002/0471142727.mb2129s109.

    PMID: 25559105BACKGROUND

  • Lake BB, Codeluppi S, Yung YC, Gao D, Chun J, Kharchenko PV, Linnarsson S, Zhang K. A comparative strategy for single-nucleus and single-cell transcriptomes confirms accuracy in predicted cell-type expression from nuclear RNA. Sci Rep. 2017 Jul 20;7(1):6031. doi: 10.1038/s41598-017-04426-w.

    PMID: 28729663BACKGROUND

  • Wagner A, Regev A, Yosef N. Revealing the vectors of cellular identity with single-cell genomics. Nat Biotechnol. 2016 Nov 8;34(11):1145-1160. doi: 10.1038/nbt.3711.

    PMID: 27824854BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Bloodsamples, including full blood, serum and plasma 2. Full thickness biopsy of the appendix

MeSH Terms

Conditions

Diabetes MellitusAppendicitisInflammatory Bowel Diseases

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jacob Antonsen, MD

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Antonsen, MD

CONTACT

+4520847551jacob.antonsen@regionh.dk

Lars N Joergensen, DMsC, MD

CONTACT

38635000lars.nannestad.joergensen@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

February 1, 2023

Primary Completion

December 30, 2023

Study Completion

June 1, 2024

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Data in this study is based on biological samples and data from patient registry. These data are protected by the Danish Act on Processing of Personal Data and can be accessed through application to and approval from the Danish Data Protection Agency and the Danish Health Data Authority \[https://sundhedsda tastyrelsen.dk/da/forskerservice/ansog-om-data\] where the purpose and the feasibility of the intended analysis should be accounted for.

Locations

DK(1)