A Retrospective Study Project of Clinico-molecular Characterization in Patients With Metastatic Colorectal Cancer

NCT04338542 | Completed

• 1 other identifier: IOSI-ICP-001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective, translational, proof-of-concept study on tumor biopsies done on patients affected by mCRC and exhibiting RAS mutation. For each patient it will be selected the tissue biopsies of primary tumour and of paired resected metastasis.

Conditions

Mestastatic ColoRectal Cancer

Outcome Measures

Primary Outcomes (1)

• Change of RAS mutant clones in the metastatic lesion

  To confirm that the administration of an antiangiogenic treatment in mCRC RAS mutant patients before liver metastasis resection leads to a significant reduction of RAS mutant clones in the metastatic lesion

  6 months

Secondary Outcomes (1)

• Molecular patterns other than RAS

  6 months

Study Arms (3)

neoadjuvant chemotherapy plus bevacizumab

Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy plus bevacizumab and, finally, the surgical resection of liver metastasis.

Genetic: Tumor biobsies analysis

neoadjuvant chemotherapy

Patients treated with surgery of the primary tumor, neoadjuvant chemotherapy and, finally, the surgical resection of liver metastasis.

Genetic: Tumor biobsies analysis

control group

Patients presenting with synchronous primary tumour and metastasis resected without any preoperative systemic therapy.

Genetic: Tumor biobsies analysis

Interventions

Tumor biobsies analysis GENETIC

Analysis on archived tumor biopsies

control group; neoadjuvant chemotherapy; neoadjuvant chemotherapy plus bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

metastatic ColoRectal Cancer patients exhibiting RAS mutation and who received a treatment

You may qualify if:

• patients with biopsy-proven, stage IV CRC;
• RAS mutation at diagnosis;
• availability of tissue biopsy/resection of both primary tumour and paired liver metastasis for the molecular characterization;

You may not qualify if:

• inadequate material for the molecular characterization of the primary tumour and/or of the related metastasis;
• insufficient amount (%) of tumour cells;
• st group:
• first-line bevacizumab plus chemotherapy before resection of liver metastases;
• metastases must be resected metachronously with respect to the primary tumor.
• nd group:
• first-line chemotherapy without bevacizumab before resection of liver metastases;
• metastases must be resected metachronously with respect to the primary tumor.
• rd group:
• no systemic therapy (immediate surgical resection of primary tumor and paired liver metastases);
• primary tumour and metastasis can be synchronous or metachronous.

Sponsors & Collaborators

• Sara De Dosso: lead
• Istituto Cantonale di Patologia: collaborator
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

Study Officials

• Sara De Dosso, MD

  Ente Ospedaliero Cantonale, Bellinzona

  STUDY CHAIR

• Milo Frattini, MD

  Istituto Cantonale Patologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Senior

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 8, 2020
• Study Start: April 8, 2020
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)