Colorectal Cancer Clinical Trial
— MRSOfficial title:
Multistate Relative Survival Modeling of Colorectal Cancer Progression and Mortality
NCT number | NCT02894801 |
Other study ID # | PIOC 2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | August 30, 2016 |
Last updated | September 5, 2016 |
Start date | January 2013 |
Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In
France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57%
in men to 60% in women. About one third of patients diagnosed with CRC will develop a
metachronous recurrence during the following years. It is of paramount importance to
accurately identify factors associated with the increased risk of progression and death, in
order to develop effective follow-up and treatment strategies. However, to accurately assess
the role of patients' specific characteristics in the progression of cancer several
methodological challenges need to be overcome.
One difficulty, common to prognostic studies of cancer, concerns the need to separate the
effects of prognostic factors on different clinical endpoints, such as disease recurrence vs
recurrence-free death. Another difficulty, encountered in prognostic studies, is that the
cause of death is not available or not accurately coded. Yet, some patients are likely to
die of causes not related to the disease of primary interest, especially in cancers with
longer survival and in those that affect older subjects. Until recently, the existing
statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to
account for (i) possibly different effects of prognostic factors on death vs recurrence, and
(ii) unknown causes of death. However, this challenge has been addressed by the recent
development of the Markov relative survival model (MRS) , which extends the Markov
multi-state model to incorporate relative survival modelling. Simulations demonstrate that
MRS is able to accurately estimate different effects of prognostic factors on the risk of
each of several events, including separate effects on disease-specific vs other causes of
death. To date, the MRS had not been applied in clinical or epidemiological studies.
The aim of this study was to assess the potential advantages of the new multi-state relative
survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To
this end, we compared the MRS results with those obtained with two more conventional
analyses, based on Cox's proportional hazards model, and the multi-state Markov model
proposed by Alioum and Commenges (2001). The three models were applied to explore the impact
of prognostic factors on cancer-specific mortality and recurrence, in a large
population-based French registry of colorectal cancer, with up to 25 years of follow-up.
Status | Completed |
Enrollment | 5194 |
Est. completion date | |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: patient with primary digestive cancer between 1985 and 2000, TNM I-III, resected for cure, residing in Burgundy or Calvados, France Exclusion Criteria: metastatic cancer, non adenocarcinoma, recurrence within 6 month |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
France | Chu Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | death due to cancer | 10 years after resection | No | |
Primary | death due to recurrence | 10 years after resection |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Not yet recruiting |
NCT05775146 -
SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
|
Phase 2 | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 |