- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02416518
Genetic Exploration of the Molecular Basis of Malignancy in Adults (GEMMA)
1 de abril de 2019 atualizado por: Sanford Health
Genetic Exploration of the Molecular Basis of Malignancy in Adults.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This protocol is not designed as a treatment protocol.
Patients enrolled on this study will be treated according to the treating physician's plan of care, independent of enrollment into the study.
Once enrolled, the physician may proceed with the appropriate plan of care during the period of specimen analysis if indicated.
Upon return of the results, therapy may or may not be altered based upon the patient's pathology, pertinent medical and treatment history, imaging studies, available clinical trials, and on the CLIA validated clinical molecular profiling results.
Regardless of the results, the patient will be offered a treatment selected on an empirical basis by the treating physician at the individual site.
All patients enrolled in the study will be followed for clinical outcome.
Clinical molecular profiling results will expire 14 weeks following the date the Foundation One report is received.
No investigational agents will be administered as part of this study.
However, patients may be referred to open clinical trials based on the results of profiling.
Patients referred for clinical trial may receive investigational agents under a separate clinical trial in accordance with the written protocol for which they are subsequently enrolled.
All anti-neoplastic drugs used while participating in this study, whether used on-label or off-label, will be administered to the patient by the route of administration published in the FDA approved package insert.
In addition, the dosing of the agent (including dose modifications) will be calculated based upon what is published in the FDA approved package insert.
Tipo de estudo
Observacional
Inscrição (Real)
120
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Minnesota
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Bemidji, Minnesota, Estados Unidos, 56601
- Sanford Health
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Sanford Health
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Fargo, North Dakota, Estados Unidos, 57102
- Sanford Health
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57104
- Sanford Health
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Adult patients with metastatic, incurable cancer or cancer with no standard 1st-line systemic therapy that has shown prolonged survival
Descrição
Inclusion Criteria:
- Understand and provide written informed consent and HIPAA Authorization prior to initiation of any study-specific procedures.
- Have a life expectancy of >3 months.
- Have a diagnosis of metastatic, incurable cancer and have progressed on at least one line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown to prolong survival (or where a clinical trial recommended as the 1st-line option). Patients do not have to be off-treatment when enrolled on this trial. However, please see section 6.4.8 regarding the required wash-out period before starting any FDA approved on-label or off-label treatment.
- Measurable disease (RECIST 1.1).
- Be ≥18 years of age.
- ECOG Performance status 0 or 1.
- In the opinion of the investigator, be medically suitable for and willing to undergo a biopsy or surgical procedure to obtain tissue as a part of routine care for their malignancy OR have adequate archival tissue from a previous biopsy, performed no more than 14 weeks prior to enrollment, available for profiling.
- Have adequate organ and bone marrow function as defined below: Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin ≥ 9 g/dL; platelets >100 x 109/L Renal: creatinine clearance ≥ 60 mL/min (calculated according to Cockcroft and Gault formula) or creatinine ≤ 1.5 mg/dL Hepatic: bilirubin ≤ 2.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT); alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases)
- Female patients of childbearing potential must have a negative pregnancy test and agree to use at least two forms of contraception during the study and for at least one month after treatment discontinuation. For the purposes of this study, a female with child- bearing potential is defined as: any woman who meets the following criteria.
Has not undergone a hysterectomy or bilateral oophorectomy. Has not been naturally postmenopausal for at least 24 months (i.e. has had a menses at any time in the preceding 24 consecutive months).
- Male patients must use a form of barrier contraception that contains spermicide and is approved by the investigator / treating physician during the study and for at least one month after treatment discontinuation.
- No more than one prior screening attempt for SH GEMMA.
Exclusion Criteria:
- Have lesions that are not accessible to biopsy or not planned for biopsy as part of routine care OR if archival tissue will be used for profiling, an insufficient amount is available OR archival tissue was obtained ≥ 14 weeks prior to enrollment.
- Have diagnosis of a hematologic malignancy.
- Diagnosis of astrocytoma, glioblastoma multiforme, or any other primary brain cancer.
- Have concurrent uncontrolled malignancy.
- Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment.
- Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent.
- Have known HIV, HBV, HCV infection.
- Previous enrollment in the SH GEMMA study. Patients are allowed one prior screening attempt.
- Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feasibility (proportion of patients with successful molecular profiling compared to the number of patients enrolled)
Prazo: 12 months
|
Assess the feasibility of integrating genomic profiling in the adult oncology clinic within a community-based, multi-facility, health system.
Feasibility is defined as the proportion of patients with successful molecular profiling compared to the number of patients enrolled.
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12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patient and biopsy characteristics (including cancer type, biopsy type, and number of prior treatments)
Prazo: 12 months
|
Determine patient and biopsy characteristics, including cancer type, biopsy type, and number of prior treatments
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12 months
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Molecular testing characteristics (include: the frequency at which molecular analysis yields a genetic alteration, frequency of actionable alterations, and time from biopsy to final report)
Prazo: 12 months
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Define molecular testing characteristics.This will include: the frequency at which molecular analysis yields a genetic alteration, frequency of actionable alterations, and time from biopsy to final report.
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12 months
|
Molecular profiling influence
Prazo: 12 months
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Determine how often molecular profiling influences treatment decision.Treatment type implemented will be classified as: standard therapy per treating physician, FDA approved off-label influenced by molecular profiling, internal targeted agent clinical trial influenced by molecular profiling, or external targeted agent clinical trial influenced by molecular profiling.
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12 months
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Clinical outcome of genomic based therapy (response according to RECIST 1.1 response criteria)
Prazo: At 16wks following initiation of treatment impacted by molecular profiling. After 16wks tumor assessments per routine practice/clinical trial protocol requirements, continued until progression/time of treatment discontinuation, whichever is later.
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Determine the clinical outcome of genomic based therapy, as defined by response rate (according to RECIST 1.1 response criteria) the percent of patients with progression-free survival (PFS) at 4 months, and overall survival.
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At 16wks following initiation of treatment impacted by molecular profiling. After 16wks tumor assessments per routine practice/clinical trial protocol requirements, continued until progression/time of treatment discontinuation, whichever is later.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Steven Powell, MD, Sanford Health
- Investigador principal: Anu Gaba, MD, Sanford Health
- Investigador principal: John Reynolds, MD, Sanford Health
- Investigador principal: Jayan Nair, MD, Sanford Health
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2014
Conclusão Primária (Real)
1 de março de 2018
Conclusão do estudo (Real)
1 de dezembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
15 de agosto de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de abril de 2015
Primeira postagem (Estimativa)
15 de abril de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de abril de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de abril de 2019
Última verificação
1 de abril de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SH GEMMA
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .