Clinical trial NCT04150081: Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer
Official title: Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: T1 Colorectal Cancer
Early Colorectal Cancer
Endoscopic polypectomy
Oncological Surgery
Lymph node metastasis
Molecular signatures
Disease free survival
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2019-11-04
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- All patients diagnosed with pT1 CRC will be included, regardless of endoscopic features, treatment received and lymph node staging

Exclusion Criteria:

* CRC with other histology than adenocarcinoma
* Patients with hereditary syndromes of CRC (Lynch syndrome, classical familial adenomatous polyposis) or inflammatory bowel disease.
* Synchronous CRC
* Metachronous CRC in the previous 5 years
* Patients with metastatic neoplastic disease at the time of diagnosis

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Disease free survival
timeFrame: 1 year
measure: Develop a predictive model of the probability of receiving surgical treatment
timeFrame: 1 year
measure: Validation of molecular signatures
timeFrame: 2 years
Secondary outcomes:
measure: Prognosis
timeFrame: 1 year
measure: Risk of lymph node metastasis
timeFrame: 1 year
measure: Concordance of histological evaluation
timeFrame: 2 years
measure: T1 CRC in screening program
timeFrame: 1 year
measure: Proportion of adverse events
timeFrame: 1 year
measure: Sensitivity and specificity of follow-up tests
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: María Pellisé. MD. PhD.
Study officials:
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