Clinical trial · Observational
Colorectal Cancer Umbrella Protocol - Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC Program) Screening Protocol
Assessment of Targeted Therapy Against Colorectal Cancer (ATTACC) Screening Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to test for biomarkers in patients with metastatic or unresectable, locally advanced colorectal cancer. Biomarkers are chemical "markers" in the tumor tissue and/or blood that may be related to your reaction to cancer drugs. This is an investigational study. This study's biomarker testing is for research purposes only. Up to 1280 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Testing | Other | — | UNRESOLVED |
| Cancer Symptom Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biomarker Assessment
- description
- Leftover sample of tumor tissue from a previous procedure used for biomarker testing. Blood drawn for biomarker testing, to check for levels of cytokines, and to check the circulating tumor cells (CTCs). Cancer Symptom Questionnaire completion about cancer symptoms.
- interventionNames
- Behavioral: Cancer Symptom Questionnaire
- Other: Biomarker Testing
Primary outcomes (1)
- measure
- Rate of Successful Biomarker Determination
- timeFrame
- +/- 7 days
- description
- Descriptive analysis performed to report the frequency of informative biomarkers for each of the companion allocation biomarkers as a proportion of patients enrolled onto the study. The primary analysis will be number of patients where informative biomarker results were determined for all tested biomarkers divided by the total number of patients enrolled on the study. Results reported separately for each of the individual biomarkers. Reasons for non-informative results reported descriptively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient has a histologically or cytologically confirmed colorectal adenocarcinoma with metastatic or unresectable, locally advanced disease documented on diagnostic imaging studies. 2. The patient must have been previously treated with systemic chemotherapy for metastatic or unresectable, locally advanced colorectal cancer, with no limit on the number of prior regimens. Patients who develop recurrent or metastatic disease on or within 6 months of adjuvant therapy are eligible. 3. Age \>/=18 years to provide a uniform oncologic phenotype of adult-onset colorectal cancer. 4. ECOG performance status 0-2. 5. The patient has signed informed consent. Exclusion Criteria: 1\) Inability to comply with study and/or follow-up procedures.
References
Publications (1)
- DERIVEDOverman MJ, Morris V, Kee B, Fogelman D, Xiao L, Eng C, Dasari A, Shroff R, Mazard T, Shaw K, Vilar E, Raghav K, Shureiqi I, Liang L, Mills GB, Wolff RA, Hamilton S, Meric-Bernstam F, Abbruzzese J, Morris J, Maru D, Kopetz S. Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials. Ann Oncol. 2016 Jun;27(6):1068-1074. doi: 10.1093/annonc/mdw073. Epub 2016 Feb 18. PMID 27045102