NCT05595811

Brief Summary

Especially since the Second World War the indigenous population in the Arctic, the Inuit have gone through a Westernization, which has improved the health conditions but also changed the disease panorama with an increasing incidence of cancer. This is exemplified by a decrease in physical activity, due to the depletion of the Greenlandic hunting traditions, tobacco smoking and unhealthy diet. At the beginning of the westernization, malignant diseases were highly uncommon, but they started to increase due to the increasing life expectancy and changes in lifestyle. The incidence of pancreatic and periampullary cancer has been reported to be the same among Inuit in Canada, Denmark, and the United States but with a higher incidence than among the Caucasian population in the three countries. The aim with this study was to investigate the results of pancreatic surgery for pancreatic and periampullary tumors in Inuit patients in Greenland at to compare the outcome of surgery and the overall survival with a cohort of Danish patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 1999

Completed
23 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
Last Updated

November 30, 2023

Status Verified

October 1, 2022

Enrollment Period

23 years

First QC Date

October 14, 2022

Last Update Submit

November 26, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • waiting time from diagnosis to surgery

    time from diagnosis to surgery for each patient

    from 31. January 1999 to 31. January 2021

  • number and kind of postoperative complications

    anastomosis leak, bleeding, death of any reason, in-hospital

    31. January 1999 to 31. January 2021

  • overall survival

    from operation to death of any course

    31. January 1999 to 31. January 2022

Secondary Outcomes (1)

  • adjuvant oncologic treatment

    31. January 1999 to 31. January 2021

Study Arms (2)

Inuit

Inuit living in Greenland

Other: outcome following surgery

Danish

Danish patients living in Denmark

Other: outcome following surgery

Interventions

Eligibility Criteria

Age41 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Greenland Inuit, both sex, living in Greenland and operated at Copenhagen University Hospital Rigshospitalet Danish patients (controls), both sex living in Denmark and operated at Copenhagen University Hospital Rigshospitalet

You may qualify if:

  • Greenland Inuit patients
  • operated for pancreatic and periampullary cancer
  • time of operation 31. January 1999 to 31. January 2021
  • sex: all
  • minimum age: 41 years
  • maximum years: 79 years

You may not qualify if:

  • patients beyond the age limit
  • patients operated beyond the time limit
  • Danish patients
  • operated for pancreatic and periampullary cancer
  • time of operation 31. January 1999 to 31. January 2021
  • sex: all
  • minimum age: 41 years
  • maximum years: 79 years
  • patients beyond the age limit.
  • time of operation 31. January 1999 to 31. January 2021

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (27)

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    PMID: 28129987BACKGROUND
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    PMID: 30575490BACKGROUND
  • Mathew G, Agha R; STROCSS Group. STROCSS 2021: Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery. Ann Med Surg (Lond). 2021 Nov 6;72:103026. doi: 10.1016/j.amsu.2021.103026. eCollection 2021 Dec.

    PMID: 34820121BACKGROUND
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    PMID: 8813062BACKGROUND
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    PMID: 22456038BACKGROUND
  • Engholm G, Ferlay J, Christensen N, Bray F, Gjerstorff ML, Klint A, Kotlum JE, Olafsdottir E, Pukkala E, Storm HH. NORDCAN--a Nordic tool for cancer information, planning, quality control and research. Acta Oncol. 2010 Jun;49(5):725-36. doi: 10.3109/02841861003782017.

    PMID: 20491528BACKGROUND
  • Bosetti C, Lucenteforte E, Silverman DT, Petersen G, Bracci PM, Ji BT, Negri E, Li D, Risch HA, Olson SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P, Baghurst PA, Zatonski W, Fontham E, Bamlet WR, Holly EA, Bertuccio P, Gao YT, Hassan M, Yu H, Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Boffetta P, La Vecchia C. Cigarette smoking and pancreatic cancer: an analysis from the International Pancreatic Cancer Case-Control Consortium (Panc4). Ann Oncol. 2012 Jul;23(7):1880-8. doi: 10.1093/annonc/mdr541. Epub 2011 Nov 21.

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    PMID: 32433397BACKGROUND
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    PMID: 34107227BACKGROUND
  • Bjerregaard P, Larsen CVL. Social determinants of dietary patterns, food basket costs and expenditure on alcohol and tobacco amongst Greenland Inuit. Public Health Nutr. 2021 Oct;24(15):4975-4984. doi: 10.1017/S1368980020005133. Epub 2021 Jan 19.

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  • Pedersen ML. Diabetes mellitus in Greenland. Dan Med J. 2012 Feb;59(2):B4386.

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  • Nielsen MH, Backe MB, Pedersen ML. Prevalence of patients using antihypertensive medication in Greenland, and an assessment of the importance of diagnosis for the associated quality of care - a cross-sectional study. Int J Circumpolar Health. 2022 Dec;81(1):2110675. doi: 10.1080/22423982.2022.2110675.

    PMID: 35938701BACKGROUND
  • Lavoie JG, Stoor JP, Rink E, Cueva K, Gladun E, Larsen CVL, Healey Akearok G, Kanayurak N. Cultural competence and safety in Circumpolar countries: an analysis of discourses in healthcare. Int J Circumpolar Health. 2022 Dec;81(1):2055728. doi: 10.1080/22423982.2022.2055728.

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  • Tolstrup J, Madsen RC, Sneftrup MV, Niclasen B. Greenlandic patients with colorectal cancer: symptomatology, primary investigations and differences in diagnostic intervals between Nuuk and the rest of the country. Int J Circumpolar Health. 2017;76(1):1344086. doi: 10.1080/22423982.2017.1344086.

    PMID: 28705121BACKGROUND
  • van Walraven C, McAlister FA. Competing risk bias was common in Kaplan-Meier risk estimates published in prominent medical journals. J Clin Epidemiol. 2016 Jan;69:170-3.e8. doi: 10.1016/j.jclinepi.2015.07.006. Epub 2015 Jul 29.

    PMID: 26232083BACKGROUND
  • Augustussen M, Hounsgaard L, Pedersen ML, Sjogren P, Timm H. Relatives' level of satisfaction with advanced cancer care in Greenland - a mixed methods study. Int J Circumpolar Health. 2017;76(1):1335148. doi: 10.1080/22423982.2017.1335148.

    PMID: 28613119BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • carsten p hansen

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 27, 2022

Study Start

January 1, 1999

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 30, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.