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ctDNA and TEP Levels in Colon Cancer

8 luglio 2026 aggiornato da: Institute of Oncology Ljubljana

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Tanja Mesti, MD
  • Numero di telefono: +386 1 5879 287
  • Email: tmesti@onko-i.si

Luoghi di studio

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Procedura: Additional Peripheral Venous Blood Sampling 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Objective Radiological Response According to RECIST 1.1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Institute of Oncology Ljubljana

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 giugno 2028

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ORI2026-25

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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