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NCT05455606

Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from SWOG Cancer Research Network

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Record History

All 9 versions: 8 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 29 words
    • Primary completion pushed from Dec 15, 2026 to Mar 1, 2027
    • Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 9 of 72 sites
  2. Primary completion date: Dec 15, 2025 to Dec 15, 2026
    • Study completion date: Dec 15, 2025 to Mar 1, 2027
    v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1182 to confirmed 1284
    • Site details revised at 72 of 72 sites
    v7
  4. Start date: Nov 2, 2022 to Oct 14, 2022v5
  5. Study sites: 2 to 72v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Aug 22, 2022 to Nov 2, 2022v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Aug 23, 2022 to Aug 22, 2022
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percent of patients who receive a treatment that targets a genomic variant for which there is sufficient data to support actionability
Timeframe: Within 6 months of study completion

Secondary (6)

Physician genomic confidence
Physician experience using genomic tumor testing (GTT) in practice
Overall survival
Overall survival on new anticancer therapy
Time to treatment discontinuation
Show 1 moreShow less
Time to treatment discontinuation on new anticancer therapy

Arms and interventions

Arm 1 (usual care)Active comparator

Participants receive usual care. This consists of physicians ordering GTT for patients and reviewing the results without the GTB being involved.

Arm 2 (EGTB)Experimental

Patients and physicians receive the EGTB intervention. This is comprised of 2 components: the structured GTB and the supporting education. Physicians submit cases for discussion to the GTB within 2 weeks of GTT results. The GTB sessions are held weekly and conducted virtually over a video-conferencing platform. Each case presentation is 10 to 15 minutes long, and 4 to 6 cases are discussed during each 60 minute GTB session. GTT results and clinical data are presented and expert interpretation of genomic test results is provided to help prioritize potential treatment options and provide a framework for interpretation. Supporting education materials are also available online to participants to support GTT decision making.

Other: Best Practice, Chart Abstraction, Educational Intervention, Interview, Questionnaire Administration, Tumor Board Review

Procedures: Genomic Profile

Sites

72 sites in 2 countries

United States 70, Puerto Rico 2