ctDNA e Preservação de Órgãos/RC Patológica em Câncer Retal
Um estudo do papel do DNA tumoral circulante na previsão da probabilidade de preservação de órgãos ou resposta patológica completa após terapia neoadjuvante para câncer retal
This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care
C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care.
It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study .
Participants enrolled on the study will remain on study for up to 60 months.
Tipo de estudo
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Descrição
Inclusion Criteria:
- Participants with T3, T4, or node-positive non-metastatic rectal cancer.
- Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
- Participants must be 18 years of age or older.
- ECOG 0-2.
- Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
- Participants must be eligible for long course chemoradiation to 40-54 Gy.
- Participants must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Participants must not have any other organ cancer evident at the time of enrollment.
- Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
- Participants must not be actively or planning to be pregnant or breastfeeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
EVALUATION OF CTDNA
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care - Except for the initial research biopsy, quality of life assessments and ctDNA collection |
initial research biopsy, quality of life assessments and ctDNA collection |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Taxa de gerenciamento não operacional bem-sucedido
Prazo: 1 ano
|
1 ano
|
|
Taxa de resposta patológica completa bem-sucedida
Prazo: 1 ano
|
1 ano
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Rate of local recurrence
Prazo: 5 years
|
Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay. |
5 years
|
|
EORTC-QLQ-CR 29 questionnaire
Prazo: Up to 30 months
|
European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer. Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning. |
Up to 30 months
|
|
FACT-C questionnaire
Prazo: Up to 30 months
|
Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life. |
Up to 30 months
|
|
IADL Scale
Prazo: Up to 30 months
|
Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function). IADLs are things you do every day to independently take care of yourself and your home. |
Up to 30 months
|
|
Brief Pain Inventory (BPI) questionnaire
Prazo: Up to 30 months
|
Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer. BPI scale total score:
|
Up to 30 months
|
|
Bowel function assessment with LARS score
Prazo: Up to 30 months
|
Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer. LARS total score:
|
Up to 30 months
|
|
Bowel function assessment with FISI score
Prazo: Up to 30 months
|
Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life. Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life. |
Up to 30 months
|
|
Bowel function assessment with FIQOL score
Prazo: Up to 30 months
|
Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life. |
Up to 30 months
|
|
Disease-free survival (DFS)
Prazo: Up to 30 months
|
Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer. |
Up to 30 months
|
|
Overall Survival (OS)
Prazo: Up to 30 months
|
Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive. |
Up to 30 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hannah J. Roberts, MD, Massachusetts General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 22-244
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Prazo de Compartilhamento de IPD
Data can be shared no earlier than 1 year following the date of publication
Critérios de acesso de compartilhamento IPD
Contact the Partners Innovations team at http://www.partners.org/innovation
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
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