Pancreatic NeoplasmsNCT05595811
Pancreatic and Periampullary Tumors in Greenland Inuit
An observational study of Pancreatic Neoplasms and Periampullary Neoplasms, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 79 years
- Conditions the study is for
- Pancreatic Neoplasms, Periampullary Neoplasms
- What is being tested?
- outcome following surgery
- How many people
- 2,326 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 31 Dec 2021
- 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 41 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- minimum age: 41 years
- maximum years: 79 years
- patients beyond the age limit.
- time of operation 31. January 1999 to 31. January 2021
About this study
Official title: The Outcome After Operation for Pancreatic and Periampullary Tumors in Greeland Inuit.
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.
Read the detailed description
Study design. The study is a retrospective, descriptive register study based on data from a prospectively maintained database. The study is a comparison of two cohorts, all Inuit patients living in Greenland, who had pancreatic operations for pancreatic and periampullary tumors - either preoperatively verified or suspected - at Rigshospitalet, Copenhagen University Hospital from 31. January 1999 to 31. January 2021. Danish patients living in Greenland were not included in the study. Inuit patients were compared with a cohort of Danish patients with same diagnosis and same range of age operated during the same period at the hospital. All diagnoses were histologically verified. Data recruitment include all patients operated between January 31, 1999 and January 31, 2021 with follow-up until December 31 after which data will be evaluated. The study is reported according to the STROCSS guidelines (www.strocssguideline.com).
Study population. The study includes 2326 consecutive patients, 47 inuit and 2279 Danish patients between 41 and 79 years (age range based on the inuit patients). There are 1,208 patients with malignant tumours of whom 1,020 have adenocarcinoma.
Data collection Data are collected from our prospectively maintained database of pancreatic operations, from the electronic hospital record systems Orbit and EPIC, the Danish National Pathology Data Registry, and from the National Register of Death. All Danish Nationals including citizens in Greenland have a unique Central Person Registration number that enables searching of health data.
Outcomes. Relevant postoperative complications are recorded in the study and include leakage from the pancreatic, bile or gastrojejunal anastomosis, intraabdominal hemorrhage and abscess formation or other complications with severe or fatal outcome. Outcomes are defined as postoperative complications and mortality assessed during 30- and 90-days and overall survival (OS) defined as the time from surgery to death from any cause or censoring at time of last follow-up. Hospitalization is defined as postoperative stay until discharge. In-hospital mortality is defined as all deaths from time of admission until discharge. Cancer specific mortality is defined as death from adenocarcinoma after other causes are censured.
Statistics. Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and are analyzed with Fisher's exact test. Non-parametric continuous data between subgroups are analyzed with the Mann-Whitney test. The Kaplan-Meier method and the cumulative incidence function with correction for competing risks are used to estimate OS and the log-rank test to examine the differences between curves. The reference population is an age and sex matched Danish standard population. A p < 0.05 is considered statistically significant. Statistical analysis is performed with GraphPad Prism software version 6.05. (GraphPad, La Jolla, CA).
Ethics. The study is a descriptive study and conducted in accordance with the principles stated in the Declaration of Helsinki. No approval is required according to the Danish National Health Board. The study is an observational, retrospective quality assurance project according to the guidelines of the Danish Health Data Authority (http://Sundhedsdatastyrelsen.dk). No approval is required according to the Danish National Health Board. In this respect it has to be noticed that a major part of the Greenlandic and Danish patients had died before the study was initiated, and the Regional Ethical Committee of the Capital Region of Denmark provided exemption for the study. The use of register data follows the General Data Protection Regulation of the European Union and the Danish Data Protection Agency. Patients' written consent for using health data was obtained before operation. The study and the use of data were consented by the hospital ethical
- Conditions
- Pancreatic Neoplasms, Periampullary Neoplasms
- Being tested
- outcome following surgery
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outcome following surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Inuit | Inuit living in Greenland Receives: Other: outcome following surgery | |
| Danish | Danish patients living in Denmark Receives: Other: outcome following surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
waiting time from diagnosis to surgery
time from diagnosis to surgery for each patient
Measured: from 31. January 1999 to 31. January 2021
number and kind of postoperative complications
anastomosis leak, bleeding, death of any reason, in-hospital
Measured: 31. January 1999 to 31. January 2021
overall survival
from operation to death of any course
Measured: 31. January 1999 to 31. January 2022
Secondary outcomes (1)
adjuvant oncologic treatment
numbers treated
Measured: 31. January 1999 to 31. January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Jan 1999
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, carsten palnaes hansen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- carsten p hansen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595811
- Sponsor's protocol ID
- RH-C-2022-1
- Status last verified
- Oct 2022
- First submitted
- 14 Oct 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
GBD 2017 Pancreatic Cancer Collaborators. The global, regional, and national burden of pancreatic cancer and its attributable risk factors in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):934-947. doi: 10.1016/S2468-1253(19)30347-4. Epub 2019 Oct 21.
PubMed 31648972Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26.
PubMed 30834048Bjerregaard P, Curtis T, Borch-Johnsen K, Mulvad G, Becker U, Andersen S, Backer V. Inuit health in Greenland: a population survey of life style and disease in Greenland and among Inuit living in Denmark. Int J Circumpolar Health. 2003;62 Suppl 1:3-79. doi: 10.3402/ijch.v62i0.18212.
PubMed 14527126Friborg JT, Melbye M. Cancer patterns in Inuit populations. Lancet Oncol. 2008 Sep;9(9):892-900. doi: 10.1016/S1470-2045(08)70231-6.
PubMed 18760245Circumpolar Inuit Cancer Review Working Group; Kelly J, Lanier A, Santos M, Healey S, Louchini R, Friborg J, Young K, Ng C. Cancer among the circumpolar Inuit, 1989-2003. I. Background and methods. Int J Circumpolar Health. 2008 Dec;67(5):396-407. doi: 10.3402/ijch.v67i5.18348.
PubMed 19186761Yousaf U, Engholm G, Storm H, Christensen N, Zetlitz E, Trykker H, Sejersen F, Bjerregaard P, Thygesen LC. Cancer Incidence and Mortality in Greenland 1983-2014 - Including Comparison With the Other Nordic Countries. EClinicalMedicine. 2018 Aug 29;2-3:37-49. doi: 10.1016/j.eclinm.2018.08.003. eCollection 2018 Aug-Sep.
PubMed 31193566Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
PubMed 24965263Valle JW, Palmer D, Jackson R, Cox T, Neoptolemos JP, Ghaneh P, Rawcliffe CL, Bassi C, Stocken DD, Cunningham D, O'Reilly D, Goldstein D, Robinson BA, Karapetis C, Scarfe A, Lacaine F, Sand J, Izbicki JR, Mayerle J, Dervenis C, Olah A, Butturini G, Lind PA, Middleton MR, Anthoney A, Sumpter K, Carter R, Buchler MW. Optimal duration and timing of adjuvant chemotherapy after definitive surgery for ductal adenocarcinoma of the pancreas: ongoing lessons from the ESPAC-3 study. J Clin Oncol. 2014 Feb 20;32(6):504-12. doi: 10.1200/JCO.2013.50.7657. Epub 2014 Jan 13.
PubMed 24419109Neoptolemos JP, Palmer DH, Ghaneh P, Psarelli EE, Valle JW, Halloran CM, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ma YT, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Hackert T, Jackson R, Buchler MW; European Study Group for Pancreatic Cancer. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Mar 11;389(10073):1011-1024. doi: 10.1016/S0140-6736(16)32409-6. Epub 2017 Jan 25.
PubMed 28129987Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PubMed 30575490Mathew 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.
PubMed 34820121Storm HH, Nielsen NH. Cancer of the digestive system in Circumpolar Inuit. Acta Oncol. 1996;35(5):553-70. doi: 10.3109/02841869609096987.
PubMed 8813062Kirkegaard J. Incidence of pancreatic cancer in Greenland 2000-2010. Int J Circumpolar Health. 2012 May 22;71:18368. doi: 10.3402/ijch.v71i0.18368.
PubMed 22663941Young TK, Kelly JJ, Friborg J, Soininen L, Wong KO. Cancer among circumpolar populations: an emerging public health concern. Int J Circumpolar Health. 2016 Jan 12;75:29787. doi: 10.3402/ijch.v75.29787. eCollection 2016.
PubMed 26765259Alberts SR, Kelly JJ, Ashokkumar R, Lanier AP. Occurrence of pancreatic, biliary tract, and gallbladder cancers in Alaska Native people, 1973-2007. Int J Circumpolar Health. 2012 Mar 20;71:17521. doi: 10.3402/IJCH.v71i0.17521.
PubMed 22456038
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome After Operation for Pancreatic and Periampullary Tumors in Greeland Inuit.
- ClinicalTrials.gov ID
- NCT05595811
- Acronym / sponsor ID
- RH-C-2022-1
- Conditions
- Pancreatic Neoplasms, Periampullary Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,326 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Oct 2022 (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.
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.
Detailed description
Study design. The study is a retrospective, descriptive register study based on data from a prospectively maintained database. The study is a comparison of two cohorts, all Inuit patients living in Greenland, who had pancreatic operations for pancreatic and periampullary tumors - either preoperatively verified or suspected - at Rigshospitalet, Copenhagen University Hospital from 31. January 1999 to 31. January 2021. Danish patients living in Greenland were not included in the study. Inuit patients were compared with a cohort of Danish patients with same diagnosis and same range of age operated during the same period at the hospital. All diagnoses were histologically verified. Data recruitment include all patients operated between January 31, 1999 and January 31, 2021 with follow-up until December 31 after which data will be evaluated. The study is reported according to the STROCSS guidelines (www.strocssguideline.com).
Study population. The study includes 2326 consecutive patients, 47 inuit and 2279 Danish patients between 41 and 79 years (age range based on the inuit patients). There are 1,208 patients with malignant tumours of whom 1,020 have adenocarcinoma.
Data collection Data are collected from our prospectively maintained database of pancreatic operations, from the electronic hospital record systems Orbit and EPIC, the Danish National Pathology Data Registry, and from the National Register of Death. All Danish Nationals including citizens in Greenland have a unique Central Person Registration number that enables searching of health data.
Outcomes. Relevant postoperative complications are recorded in the study and include leakage from the pancreatic, bile or gastrojejunal anastomosis, intraabdominal hemorrhage and abscess formation or other complications with severe or fatal outcome. Outcomes are defined as postoperative complications and mortality assessed during 30- and 90-days and overall survival (OS) defined as the time from surgery to death from any cause or censoring at time of last follow-up. Hospitalization is defined as postoperative stay until discharge. In-hospital mortality is defined as all deaths from time of admission until discharge. Cancer specific mortality is defined as death from adenocarcinoma after other causes are censured.
Statistics. Data are presented as median and range if not otherwise stated. Categorial data are presented as numbers or percentage and are analyzed with Fisher's exact test. Non-parametric continuous data between subgroups are analyzed with the Mann-Whitney test. The Kaplan-Meier method and the cumulative incidence function with correction for competing risks are used to estimate OS and the log-rank test to examine the differences between curves. The reference population is an age and sex matched Danish standard population. A p < 0.05 is considered statistically significant. Statistical analysis is performed with GraphPad Prism software version 6.05. (GraphPad, La Jolla, CA).
Ethics. The study is a descriptive study and conducted in accordance with the principles stated in the Declaration of Helsinki. No approval is required according to the Danish National Health Board. The study is an observational, retrospective quality assurance project according to the guidelines of the Danish Health Data Authority (http://Sundhedsdatastyrelsen.dk). No approval is required according to the Danish National Health Board. In this respect it has to be noticed that a major part of the Greenlandic and Danish patients had died before the study was initiated, and the Regional Ethical Committee of the Capital Region of Denmark provided exemption for the study. The use of register data follows the General Data Protection Regulation of the European Union and the Danish Data Protection Agency. Patients' written consent for using health data was obtained before operation. The study and the use of data were consented by the hospital ethical
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inuit | – | Other: outcome following surgeryInuit living in Greenland |
| Danish | – | Other: outcome following surgeryDanish patients living in Denmark |
Who may qualify
- Ages
- 41 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| outcome following surgery | Other | Danish, Inuit |
Primary outcome
waiting time from diagnosis to surgery
Time frame: from 31. January 1999 to 31. January 2021
time from diagnosis to surgery for each patient
number and kind of postoperative complications
Time frame: 31. January 1999 to 31. January 2021
anastomosis leak, bleeding, death of any reason, in-hospital
overall survival
Time frame: 31. January 1999 to 31. January 2022
from operation to death of any course
1 secondary outcome
adjuvant oncologic treatment
Time frame: 31. January 1999 to 31. January 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Background: PubMed 31648972GBD 2017 Pancreatic Cancer Collaborators. The global, regional, and national burden of pancreatic cancer and its attributable risk factors in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):934-947. doi: 10.1016/S2468-1253(19)30347-4. Epub 2019 Oct 21.
- Background: PubMed 30834048Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166. Epub 2019 Feb 26.
- Background: PubMed 14527126Bjerregaard P, Curtis T, Borch-Johnsen K, Mulvad G, Becker U, Andersen S, Backer V. Inuit health in Greenland: a population survey of life style and disease in Greenland and among Inuit living in Denmark. Int J Circumpolar Health. 2003;62 Suppl 1:3-79. doi: 10.3402/ijch.v62i0.18212.
- Background: PubMed 18760245Friborg JT, Melbye M. Cancer patterns in Inuit populations. Lancet Oncol. 2008 Sep;9(9):892-900. doi: 10.1016/S1470-2045(08)70231-6.
- Background: PubMed 19186761Circumpolar Inuit Cancer Review Working Group; Kelly J, Lanier A, Santos M, Healey S, Louchini R, Friborg J, Young K, Ng C. Cancer among the circumpolar Inuit, 1989-2003. I. Background and methods. Int J Circumpolar Health. 2008 Dec;67(5):396-407. doi: 10.3402/ijch.v67i5.18348.
- Background: PubMed 31193566Yousaf U, Engholm G, Storm H, Christensen N, Zetlitz E, Trykker H, Sejersen F, Bjerregaard P, Thygesen LC. Cancer Incidence and Mortality in Greenland 1983-2014 - Including Comparison With the Other Nordic Countries. EClinicalMedicine. 2018 Aug 29;2-3:37-49. doi: 10.1016/j.eclinm.2018.08.003. eCollection 2018 Aug-Sep.
- Background: PubMed 24965263Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
- Background: PubMed 24419109Valle JW, Palmer D, Jackson R, Cox T, Neoptolemos JP, Ghaneh P, Rawcliffe CL, Bassi C, Stocken DD, Cunningham D, O'Reilly D, Goldstein D, Robinson BA, Karapetis C, Scarfe A, Lacaine F, Sand J, Izbicki JR, Mayerle J, Dervenis C, Olah A, Butturini G, Lind PA, Middleton MR, Anthoney A, Sumpter K, Carter R, Buchler MW. Optimal duration and timing of adjuvant chemotherapy after definitive surgery for ductal adenocarcinoma of the pancreas: ongoing lessons from the ESPAC-3 study. J Clin Oncol. 2014 Feb 20;32(6):504-12. doi: 10.1200/JCO.2013.50.7657. Epub 2014 Jan 13.
- Background: PubMed 28129987Neoptolemos JP, Palmer DH, Ghaneh P, Psarelli EE, Valle JW, Halloran CM, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ma YT, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Hackert T, Jackson R, Buchler MW; European Study Group for Pancreatic Cancer. Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial. Lancet. 2017 Mar 11;389(10073):1011-1024. doi: 10.1016/S0140-6736(16)32409-6. Epub 2017 Jan 25.
- Background: PubMed 30575490Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
- Background: PubMed 34820121Mathew 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.
- Background: PubMed 8813062Storm HH, Nielsen NH. Cancer of the digestive system in Circumpolar Inuit. Acta Oncol. 1996;35(5):553-70. doi: 10.3109/02841869609096987.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
carsten p hansen principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Periampullary Neoplasms, run by Copenhagen University Hospital, Rigshospitalet.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waiting time from diagnosis to surgery (time frame: from 31. January 1999 to 31. January 2021). The study lists 3 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 NCT05595811, which also lists 27 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 30 Nov 2023.