An observational study in Colorectal Cancer, sponsored by Hospital Clinic of Barcelona. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Hospital Clinic of Barcelona · Observational
The implementation of population screening programs for colorectal cancer (CRC) has led to a considerable increase in the prevalence T1 CRC originating on polyps amenable by endoscopy. The benefits of secondary oncological surgery in terms of disease free survival are not well established.
Hypothesis: The characteristics of the individuals and the polyp (endoscopic, histological) should allow us to discriminate T1 CRCs that may benefit from secondary surgery from those that only require local treatment. With the current criteria, the management of patients with T1 CRC is suboptimal since a high proportion of patients are refered for unnecessary surgeries without a clear benefit in terms of survival. Molecular signatures can help to discriminate those patients with good prognosis that do not require secondary surgery nor cancer related follow up.
The primary objective of the study is to compare the effect of oncological surgery versus local treatment for the management of polyps with T1 CRC in relation to disease-free survival and morbi-mortality of the therapeutic procedure. We will also validate molecular signatures in endoscopic samples for the prediction of lymph node metastasis and survival. Methodology: Clinical Study: Retrospective population-based cohort study that will include baseline clinical and follow up data of more than 1400 T1 CRCs in at least 10 Spanish autonomous communities from 2007 to 2017. A centralized pathological review will be carried out by a group of expert pathologists. Inter and intraobserver variability for histological staging will be assessed. A predictive model will be created to discriminate individuals with high probability of receiving surgical and local treatment. For those patients who have a similar probability range, the results in progression-free survival and adverse events will be compared. Translational phase: A 5miRNAs and 8mRNA signature predictive of lymph node metastasis will be assessed in 200 endoscopic samples and related with prognosis.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
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Spanish multicenter observational retrospective cohort study where all cases of pT1 CRC will be included from January 2007 to December 2017. Patients will be included both inside and outside the CCR national screening program.
Exclusion Criteria:
All the patients in the cohort will receive surgery o local (endoscopic) treatment, in some cases additional surgical treatment will be performed after an endoscopic primary treatment. This decision will have been taken based on daily clinical practice and does not represent a study intervention.
Overall survival
Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)
Time frame: 1 year
Disease free survival
Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)
Time frame: 1 year
Develop a predictive model of the probability of receiving surgical treatment
Determine factors associated with the choice of primary treatment and final treatment (endoscopic, primary surgery or secondary surgery) and to develop a predictive model that allow discriminate individuals with high probability of receiving surgical treatment
Time frame: 1 year
Validation of molecular signatures
Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis
Time frame: 2 years
Prognosis
Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery)
Time frame: 1 year
Risk of lymph node metastasis
Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis
Time frame: 1 year
Concordance of histological evaluation
Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria.
Time frame: 2 years
T1 CRC in screening program
Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it.
Time frame: 1 year
Proportion of adverse events
Evaluate the proportion of adverse effects after endoscopic or surgical treatment
Time frame: 1 year
Sensitivity and specificity of follow-up tests
To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence
Time frame: 1 year
Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona