Genomic Profiling Assay in Phase I
A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
Studieöversikt
Detaljerad beskrivning
If you agree to take part in this study, your tumor tissue collected previously from surgery or a prior biopsy (archived tissue) will be used for genetic testing. Genetic testing looks at whether specific genes are changed (mutated) in the tumor.
The results of the genetic testing will be documented in your medical record. Your doctor may use the results of the genetic testing to help decide which treatment you will have. While awaiting results of the genomic profile assay, you may be enrolled in another treatment either at MD Anderson or near your home. This will be decided by your treating physician.
Your samples will be given a code number when they are sent for genetic testing to Foundation Medicine. No identifying information will be directly linked to your samples. Only the researcher in charge of sending all tissue for testing will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Foundation Medicine will not be able to link this data to you.
Researchers will also review your medical history from before and following the collection of tissue, to learn if the use of genetic testing had any effect on the outcome of your treatment.
This is an investigational study.
Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77030
- University of Texas MD Anderson Cancer Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria
- Patients with advanced cancer.
- Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note: Patients may currently be enrolled in other investigational protocol including treatment protocols.
- Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase I historical archives. Patients (cases no older than 2 years) will be selected based on clinical characteristics and genomic alterations similar to matched targeted therapy group.
- Patients may have received prior 'matched' therapies; however, at the time of enrollment, patients may not currently be on a known 'matched' therapy, and may not have received a 'matched' therapy as the last treatment if not receiving treatment at the time of consent.
- Patients who have a life expectancy of greater than 3 months.
Exclusion Criteria:
- Patients with advanced cancer who are NOT likely to meet the additional enrollment criteria in matched targeted therapy protocols or treatments.
- Patients who do not have archival tissue available.
- Patients are excluded if their last treatment before enrollment included a targeted agent matched to a genomic alteration in the patient's tumor.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Control Group #1
Participants who have had tumor molecular analysis performed with the similar clinical characteristics and genomic aberrations but who receive therapy not matched to their aberrations, or who have received results from Foundation Medicine that fail to demonstrate any molecular alteration.
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Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
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Control Group #2
Participants from historical archives of MD Anderson, no older than two years, who received therapy not matched to their aberrations and are matched not only on the basis of the clinical characteristics, but also, as much as possible, on the basis of genomic aberrations.
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Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
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Matched Targeted Therapy Group
Participants with tumor aberrations who received matched targeted therapy.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Response Rate
Tidsram: 6 months
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Response rate of each of the three cohorts (matched targeted therapy group, control group #1 and control group #2) calculated along with its 95% confidence interval.
Response rate defined as proportion of participants who experience complete response (CR) or partial response (PR).
Clinical response evaluated according to the RECIST 1.1.
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6 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studiestol: Funda Meric-Bernstam, MD, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- PA12-0360
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