ctDNA and TEP Levels in Colon Cancer
Determination of ctDNA and TEP Levels in Patients With Colon Cancer Receiving Neoadjuvant Systemic Therapy
This interventional cohort study will evaluate circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) as blood-based biomarkers in adults with stage III colon cancer who are planned to receive neoadjuvant systemic therapy followed by surgical resection.
Treatment will be given according to routine clinical practice and will depend on the biological characteristics of the tumor, including mismatch repair status. Participants will provide additional blood samples at predefined time points before, during, and after treatment and surgery. These samples will be used to analyze ctDNA and TEP and to assess whether changes in these biomarkers are associated with radiological response, pathological response, and disease-free outcomes.
Approximately 80 participants will be enrolled at the Institute of Oncology Ljubljana. Participants will not receive experimental drugs as part of this study.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a prospective interventional longitudinal cohort study of adult patients with histologically confirmed stage III colon adenocarcinoma who are planned to receive neoadjuvant systemic therapy followed by surgical resection with curative intent.
The study will evaluate the dynamics of circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) during neoadjuvant treatment and follow-up. Neoadjuvant systemic therapy will be selected according to routine clinical practice and tumor biology, including mismatch repair status. Patients with pMMR tumors may receive chemotherapy, while patients with dMMR tumors may receive immunotherapy, according to standard clinical decision-making.
The research intervention consists of additional peripheral venous blood sampling at predefined time points before treatment, during systemic treatment, before surgery, and after surgery. Blood samples will be analyzed for ctDNA and TEP-based biomarkers. Clinical, radiological, pathological, and follow-up data will be collected from routine medical documentation.
The primary objective is to determine whether the presence of ctDNA after completion of neoadjuvant systemic therapy is associated with pathological tumor response, defined as major pathological response (MPR), in patients with stage III colon cancer. Secondary and exploratory objectives include evaluation of the association between ctDNA, TEP profiles, radiological response, recurrence-free outcomes, and disease-free outcomes.
Approximately 80 participants will be enrolled. The study is academic and non-commercial. Participants will not receive experimental drugs as part of this study, and all therapeutic and diagnostic procedures will follow established clinical practice.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Tanja Mesti, MD
- Número de telefone: +386 1 5879 287
- E-mail: tmesti@onko-i.si
Locais de estudo
-
-
-
Ljubljana, Eslovênia, 1000
- Institute of Oncology Ljubljana
-
Contato:
- Klavdija Korošec
- Número de telefone: +38631630065
- E-mail: kkorosec@onko-i.si
-
Contato:
- Tanja Mesti, MD
- Número de telefone: +386 1 5879 287
- E-mail: tmesti@onko-i.si
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18 years or older at the time of enrollment.
- Histologically confirmed adenocarcinoma of the colon.
- Stage III colon cancer, defined according to the applicable TNM classification based on clinical and imaging assessment.
- Confirmed mismatch repair (MMR) status, determined by immunohistochemistry and/or molecular methods.
- Planned neoadjuvant systemic therapy according to MMR status, followed by surgical resection with curative intent.
- ECOG performance status 0-2.
- Ability to understand the study and provide written informed consent.
Exclusion Criteria:
- Stage I, II, or IV colon cancer.
- Concurrent active malignant disease, except adequately treated non-melanoma skin cancer or carcinoma in situ.
- Severe comorbidities or medical conditions that prevent or substantially limit neoadjuvant systemic therapy or surgical resection.
- Known autoimmune disease requiring active immunosuppressive treatment in patients with dMMR tumors.
- Pregnancy or breastfeeding.
- Inability or unwillingness to provide written informed consent.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Biomarker Assessment Cohort
Participants with stage III colon cancer receiving neoadjuvant systemic therapy according to routine clinical practice will undergo additional peripheral venous blood sampling at predefined time points for ctDNA and TEP biomarker analysis.
|
Additional peripheral venous blood samples will be collected at predefined time points before treatment, during systemic treatment, before surgery, and after surgery.
Samples will be analyzed for circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
Prazo: From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Major pathological response will be assessed by histopathological evaluation of the surgical resection specimen after completion of neoadjuvant systemic therapy.
The unit of measure will be the percentage of participants with major pathological response.
ctDNA status after completion of neoadjuvant systemic therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Objective Radiological Response According to RECIST 1.1
Prazo: From baseline to preoperative radiological assessment, approximately 3 to 6 months.
|
Radiological response will be assessed according to RECIST version 1.1 using routine preoperative imaging.
Objective radiological response will include complete response and partial response.
The unit of measure will be the percentage of participants with objective radiological response.
ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to preoperative radiological assessment, approximately 3 to 6 months.
|
|
Percentage of Participants Alive and Disease-Free at 12 Months After Surgical Resection
Prazo: 12 months after surgical resection.
|
Disease-free status will be assessed using routine clinical, radiological, and follow-up documentation.
The outcome will be defined as being alive and without disease recurrence at 12 months after surgical resection.
The unit of measure will be the percentage of participants alive and disease-free at 12 months.
ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
|
12 months after surgical resection.
|
|
Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative ctDNA Assessment
Prazo: Up to 12 months after surgical resection.
|
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation.
The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection.
Postoperative ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
Up to 12 months after surgical resection.
|
|
Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative TEP Assessment
Prazo: Up to 12 months after surgical resection.
|
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation.
The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection.
Postoperative tumor-educated platelet status will be used as a pre-specified stratification variable in the statistical analysis.
|
Up to 12 months after surgical resection.
|
|
Percentage of Participants With Major Pathological Response in the Baseline ctDNA Assessment
Prazo: From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Major pathological response will be assessed by histopathological evaluation of the surgical resection specimen.
The unit of measure will be the percentage of participants with major pathological response.
Baseline ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
|
Percentage of Participants With Pathological Complete Response After Surgical Resection
Prazo: From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Pathological complete response will be assessed by histopathological evaluation of the surgical resection specimen.
The unit of measure will be the percentage of participants with pathological complete response.
Baseline ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
|
From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.
|
Colaboradores e Investigadores
Patrocinador
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
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Colorretais
- Neoplasias Intestinais
- Doenças do cólon
- Neoplasias colônicas
- Ácidos nucleicos livres de células
- Ácidos nucleicos
- Ácidos nucleicos, nucleotídeos e nucleosídeos
- DNA, neoplasia
- DNA
- DNA do tumor circulante
Outros números de identificação do estudo
- ORI2026-25
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .