An interventional study of Tumor Genomic Analysis in Medullary Thyroid Cancer and Colon Cancer, sponsored by Icahn School of Medicine at Mount Sinai. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
The Personalized Discovery Process is the only program offering patients treatment recommendations based on an empirically constructed Drosophila "fly" model of their disease. Special committee selects one of the one of the few 2-3 FDA approved drug combinations or single agents that improved survival in the fly cancer model.
Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard used in medullary thyroid or colorectal cancer.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 10 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of significant cardiac disease defined as:
Personalized Therapy Plan Patients with Metastatic Medullary or Colon Cancer being treated with the Personalized Treatment Plan developed during the different tumor genomic analysis study.
Other: Tumor Genomic Analysis
Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard. Patient will be offered an unique "personalized" single drug or combination of drugs, all FDA approved, based on the Drosophila drug screening process.
Overall response rate (ORR)
ORR as the sum of partial responses (PRs) and complete responses (CRs)
Time frame: up to 3 years
Progression-free Survival (PFS)
The length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse.
Time frame: up to 3 years
Overall survival (OS)
The length of time from either the date of diagnosis or the start of treatment for disease, that patients diagnosed with the disease are still alive.
Time frame: up to 3 years
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai