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ctDNA and TEP Levels in Colon Cancer

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Institute of Oncology Ljubljana
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Procedure: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Objective Radiological Response According to RECIST 1.1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Oncology Ljubljana

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORI2026-25

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