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OpenTrials
Completed

NCT Number: NCT00491140

Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

The primary objective is to identify molecular features predicting response or resistance to cetuximab

Completed

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion criteria

  • Less than 3 weeks after completion of previous radiotherapy

Treatment and study plan

Gene mutations analysis and FISH

Genetic

FISH and mutation analysis of multiple genes

Primary outcomes

  1. Association of different biomarkers with Cetuximab sensitivity

    Time frame: Assessment every two months

Secondary outcomes

  1. Association of different biomarkers with time to progression and survival

    Time frame: At the end of the study

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Retrospective Study Assessing Molecular Features Predicting Response or Resistance to Cetuximab Therapy in Metastatic Colorectal Cancer Patients

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 25, 2007
Registry last updated
Oct 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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