Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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.

Surgery or Endoscopic treatment

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.

Tissue samples. A 10μm slice of the FFPE block will be obtained after manual microdissection of the area with cancer. The molecular study will be carried out in patients who have signed a biobank informed consent prior to the start of this study.

Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer

Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer: a Population-based Cohort Study

Evaluate the effect of surgery and local (endoscopic) treatment on overall survival (expressed in months)

Evaluate the effect of surgery and local (endoscopic) treatment on disease free survival (expressed in months)

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

Evaluate the validity of molecular signatures based on mRNA and miRNA (determined in endoscopic samples) for prediction lymph node metastasis

Determine the prognosis of patients with pT1CRC in relation to the treatment received (local, primary surgery or secondary surgery)

Evaluate the factors of the individual and the polyp that are associated with lymph node metastasis

Evaluate the inter-intraexplorer concordance of the pathologists for the histological staging criteria.

Compare the characteristics of the T1 CRCs diagnosed within a population screening program and outside it.

Evaluate the proportion of adverse effects after endoscopic or surgical treatment

To evaluate the performances of the different tests (CT, US, blood markers, colonoscopy) during follow up for detecting recurrence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer	NCT04150081	Colorectal Canc...	Surgery or Endo...	-	Hospital Clinic of Barcelona
Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer	NCT04150081	Colorectal Canc...	Surgery or Endo...	-	Hospital Clinic of Barcelona

Spots Global Cancer Trial Database for endoscopic polypectomy