Endoscopic Versus Surgical Treatment for T1 Colorectal Cancer

NCT04150081 | Unknown

• 1 other identifier: HCB/2019/0224
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

T1 Colorectal Cancer; Early Colorectal Cancer; Endoscopic polypectomy; Oncological Surgery; Lymph node metastasis; Molecular signatures; Disease free survival

Outcome Measures

Primary Outcomes (4)

• Overall survival

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

  1 year

• Disease free survival

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

  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

  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

  2 years

Secondary Outcomes (6)

• Prognosis

  1 year

• Risk of lymph node metastasis

  1 year

• Concordance of histological evaluation

  2 years

• T1 CRC in screening program

  1 year

• Proportion of adverse events

  1 year

Interventions

Surgery or Endoscopic treatment PROCEDURE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundacion Clinic per a la Recerca Biomédica: collaborator

Study Sites (1)

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

Location

Related Publications (16)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Colorectal Neoplasms; Lymphatic Metastasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Attending physician Gastroenterology department.

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 31, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)