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ctDNA and TEP Levels in Colon Cancer

8. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Fremgangsmåte: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institute of Oncology Ljubljana

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

18. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ORI2026-25

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NEI

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Nei

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