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The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study

StatusActive, Not Recruiting
PhaseNot specified
Started2015-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jun 2026 → Dec 2026
See other at-risk trials from Dana-Farber Cancer Institute

Amendment history

2026-09-22
notable
Primary completion pushed: 2026-06 → 2026-12
Completion pushed: 2026-10 → 2026-12
2026-04-23
minor
Study Status, Oversight v14
Primary completion date2026-01→2026-06
2025-03-04
minor
Study Status, Oversight v13
Primary completion date2024-01→2026-01
Completion date2025-10→2026-10
2024-01-22
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2023-12→confirmed 2024-01
Study sitesdetails revised at 12 of 12 sites
2023-11-20
minor
Study Status v11
Primary completion date2023-09→2023-12
Show 10 earlier versions
2023-05-23
minor
Study Status, Sponsor/Collaborators v10
Primary completion date2023-04→2023-09
2022-05-02
minor
Study Status v9
Primary completion date2022-01→2023-04
Completion date2024-07→2025-10
2021-07-23
minor
Study Status, Oversight, Study Design, Arms and Interventions, Eligibility v8
PhaseNot applicable→Not specified
2021-05-10
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v7
Study sitescontacts updated at 1 of 12 sites
2021-02-01
minor
Study Status v6
Primary completion date2021-01→2022-01
Completion date2023-07→2024-07
2019-12-17
minor
Study Status, Contacts/Locations, IPDSharing v5
Primary completion date2020-01→2021-01
Completion date2022-07→2023-07
Study sites11→12
2018-08-23
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v4
Study sites10→11
Eligibility criteria+132 characters
Inclusion Criteria: Age -- Age ≤ 30 years at time of initial qualifying solid tumor diagnosis Diagnosis -- Histologic diagnosis of solid malignancy (excluding brain tu [...] ent material to meet the minimum requirements for profiling; OR Patient has already had molecular profiling and patient has not yet started matched targeted therapy based on the report . Exclusion Criteria: - No Therapy Planned -- Patients who have declined further anticancer therapy will be excluded. - Performance Status -- Patients with Lansky (age < 16 years) or Karnofsky (age ≥16 years) score < 50 will be excluded. - Life Exp [...] [...]
2017-05-31
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v3
PhaseNot specified→Not applicable
Study sites5→10
Eligibility criteria+20 characters
[...] having an expected event free survival of < 50% at 2 years. Lacks definitive diagnosis or classical genomic findings after histologic review and standard molecular testing (rare tumor group). Examples include (eligibility not limited to these examples): Histology typically associated with a fusion in which fusion is not detected. Ewing-like sarcoma Undiffere [...] Specimen Samples Sufficient tumor specimen available to meet [...] ent material to meet the minimum requirements for profiling; --- OR Patient has already had molecular profiling demonstrating a potentially targetable variant in a laboratory certi [...] [...]
Study description-11 characters
Patients with extra-cranial (not in the brain) solid tumors that are ateither highdifficult riskto for recurrencediagnose or thatmore has already recurred or become refractorydifficult to standard treatmenttreat are eligible to participate in this study. All enrolled pat [...]
Study title+43 characters
The iCat2, GAIN (Genomic Assessment Informs Novel Therapy) Consortium Study
2016-11-06
minor
Study Status, Contacts/Locations v2
Study sites2→5
2016-03-04
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2015-09→2015-10
Study sitesdetails revised at 2 of 2 sites
2015-08-07
minor
Original filing
This research study is evaluating the use of specialized testing of solid tumors including sequencing. The process of performing these specialized tests is called tumor profiling. The tumor profiling may result in identifying changes in genes of the tumor that indicate that a particular therapy may have activity. This is called an individualized cancer therapy (iCat) recommendation. The results of the tumor profiling and, if applicable, the iCat recommendation will be returned.
Trial Details
NCT Number NCT02520713
Lead Sponsor Dana-Farber Cancer Institute
Conditions Pediatric Solid Tumor
Enrollment 825 participants
Start Date 2015-10
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-21