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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02449837
Investigation of Circulating Tumor Cells From Cancer Patients Undergoing Radiation Therapy
27 de setembro de 2022 atualizado por: UNC Lineberger Comprehensive Cancer Center
The purpose of this study is to investigate the level of Circulating Tumor Cells (CTCs) in cancer patients before and after undergoing treatment regimens where the primary treatment modality is radiation therapy (XRT).
Specifically, there is interest in the change in CTCs pre- and post- XRT, both in absolute and relative terms.
Visão geral do estudo
Descrição detalhada
CTCs measurements will be taken pre- and post-RT treatment.
CTCs measurements will also be taken during treatment.
The CTCs measurements from this study will provide essential information for the power and sample size considerations for future translational studies, particularly for those looking to identify biomarkers possibly associated with CTCs and tumor response activity after XRT, and to adequately power more formal statistical comparisons of important associations between CTCs and patient characteristics and outcomes.
Tipo de estudo
Observacional
Inscrição (Real)
162
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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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill, Department of Radiation Oncology
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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 a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients undergoing radiation treatments at Lineberger Comprehensive Cancer Center at UNC Hospitals for one of eight cancer types: head and neck, cervical, rectal, lung, prostate, endometrial, metastatic breast, and oligometastatic cancer with any solid tumor histology.
Additionally, patients undergoing immunotherapy at Lineberger Comprehensive Cancer Center at UNC Hosptials, or undergoing induction chemotherapy for treatment of head and neck cancers.
Descrição
Inclusion Criteria:
- Histologically confirmed cancer, fitting one of the following cohorts: locally advanced head and neck cancer but no distant metastasis scheduled to receive radiotherapy to the head and neck region with or without chemotherapy/targeted therapy (palliative or curative intent); locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent); Stage I to III non-small cell lung cancer, without distant metastasis, scheduled to receive stereotactic body radiotherapy for early stage lung disease and/or external beam radiotherapy for locally advanced lung disease, with or without concurrent/sequential chemotherapy and/or targeted therapy (curative intent); metastatic prostate cancer scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer following radical prostatectomy; scheduled for salvage prostatic fossa radiotherapy, with or without androgen deprivation or with high risk prostate cancer; locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent); oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the primary tumor and regional lymph nodes. At least 1 site of metastatic disease, but as many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is amenable to local ablative therapy with external beam radiation, stereotactic cranial radiosurgery (SRS) or stereotactic body radiotherapy (SBRT). Treatment will be guided by multi-disciplinary evaluation and may also include surgery, chemotherapy or target agents at the discretion of the primary oncologists. Patients may present with oligometastatic disease or have oligometastatic disease recurrence after definitive therapy for localized disease; Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.; Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy; Metastatic breast cancer scheduled to receive any treatment, including radiation therapy and/or systemic/hormonal therapy; Stage III endometrial cancer scheduled to receive radiation therapy
- Scheduled to initiate radiation for management of their disease, and schedule accommodates blood sample collection prior to radiation
- Male and female of ≥18 years of age
- Male and female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during radiation therapy. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation (part of standard of care in radiation oncology).
- Written informed consent obtained and signed
- Able to have blood collection without excessive difficulty
Exclusion Criteria:
- Patient unwilling or unable to complete informed consent
- Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
- Currently pregnant or lactating women
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Head and Neck Cancer
Patient with locally advanced head and neck cancer but no distant metastasis scheduled to receive radiotherapy to the head and neck region with or without chemotherapy/targeted therapy (palliative or curative intent).
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Cervical Cancer
Patients with locally advanced cervical cancer without distant metastasis scheduled for radiotherapy to the pelvic region with or without chemotherapy/targeted therapy (palliative or curative intent).
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Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Non-Small Cell Lung Cancer
Patients with stage I to III non-small cell lung cancer, without distant metastasis, scheduled to receive stereotactic body radiotherapy for early stage lung disease and/or external beam radiotherapy for locally advanced lung disease, with or without concurrent/sequential chemotherapy and/or targeted therapy (curative intent).
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Rectal Cancer
Patients with locally advanced rectal cancer (no distant metastasis) scheduled to receive neoadjuvant chemoradiotherapy (curative intent).
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Metastatic Prostate Cancer
Patients with metastatic prostate cancer scheduled for palliative radiotherapy, or biochemically recurrent prostate cancer following radical prostatectomy scheduled for salvage prostatic fossa radiotherapy, with or without androgen deprivation, or with high risk prostate cancer.
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Oligometastatic Disease
Patients with oligometastatic cancer, defined as any solid malignancy with< 5 measurable sites of metastatic disease, limited to a maximum of 3 anatomic organ systems, excluding the primary tumor and regional lymph nodes.
At least 1 site of metastatic disease, but as many as all 5 sites, in addition to the primary tumor and regional lymph nodes, is amenable to local ablative therapy with external beam radiation, stereotactic cranial radiosurgery or stereotactic body radiotherapy.
Treatment will be guided by multi-disciplinary evaluation and may also include surgery, chemotherapy or target agents at the discretion of the primary oncologists.
Patients may present with oligometastatic disease or have oligometastatic disease recurrence after definitive therapy for localized disease.
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Immunotherapy
Melanoma or metastatic NSCLC scheduled to receive ipilimumab, nivolumab, and/or pembrolizumab.
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Head and Neck Induction chemotherapy
Locally advanced head and neck cancer (HNSCC) scheduled to receive induction chemotherapy followed by radiotherapy.
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Metastatic Breast Cancer
Patients scheduled to receive any treatment, including radiation therapy, and/or systemic/hormonal therapy
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
Endometrial Cancer
Patients with stage III endometrial cancer, being treated with adjuvant radiation
|
Blood samples will be collected at up to 4 time points before and during radiation.
Blood will be collected at least 4 to 12 weeks post-treatment.
Additional post-treatment blood draws will be performed at each subsequent follow-up visit to UNC (roughly ~1 month interval), up until 24 months after completion of radiation.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
To measure CTCs levels to evaluate the change pre- and post-treatment separately in 10 cohorts of patients receiving radiation therapy.
Prazo: 24 months post-radiation
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24 months post-radiation
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Change in CTC levels from Baseline to Post-RT treatment and the correlation with local tumor response or pathological evaluation, depending on cohort
Prazo: 24 months post-radiation
|
24 months post-radiation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Dana Casey, MD, University of North Carolina, Chapel Hill
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 (Real)
1 de maio de 2014
Conclusão Primária (Real)
20 de fevereiro de 2022
Conclusão do estudo (Real)
20 de fevereiro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
7 de abril de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de maio de 2015
Primeira postagem (Estimativa)
20 de maio de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de setembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de setembro de 2022
Última verificação
1 de setembro de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LCCC1408
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 .
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