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A Biomarker Exploration Study for Predicting Localization of Recurrence and Metastasis in Colorectal Cancer (PROBE Study) (PROBE)

30. juni 2026 oppdatert av: The First Affiliated Hospital with Nanjing Medical University

A Multicenter, Observational Clinical Study Evaluating the Application of Multi-Omics Tumor-agnostic Technology for Localizing Postoperative Local Recurrence and Distant Metastasis in Colorectal Cancer

With high incidence and mortality rate, the effective therapeutic options of colorectal cancer remain limited. Up to 50% of patients with colorectal cancer will develop metastatic disease. Recurrent lesions can be diagnosed and characterized only when tumors have reached a certain volume by present radiologic imaging techniques such as CT and MRI. The exploration of differentiated clinical applications specifically for local recurrence versus distant metastasis remains an unmet need. The aim of this study is to explore methylation, fragmentomic, and cfRNA markers associated with local recurrence and distant metastasis of colorectal cancer by multi-omics approaches. By constructing a predictive model for the localization of post-treatment recurrence and metastasis, this study will compare the accuracy of different technical approaches in predicting the localization of recurrence and metastasis after colorectal cancer treatment.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Metastatisk tykktarmskreft (CRC)

Studietype

Observasjonsmessig

Registrering (Antatt)

586

Kontakter og plasseringer

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

Studiekontakt

Navn: Yanhong Gu, PhD
Telefonnummer: +025-68307881
E-post: YanhongGu@njmu.edu.cn

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

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients meeting the following tumor types: primary colorectal cancer, locally recurrent colorectal cancer, colorectal cancer liver metastasis, colorectal cancer lung metastasis, colorectal cancer peritoneal metastasis, colorectal cancer bone metastasis, colorectal cancer multi-organ metastasis, primary liver cancer, primary lung cancer, primary peritoneal cancer, primary bone tumor.

Beskrivelse

Inclusion Criteria:

Age ≥ 18 years, male or female.
Patients with the following tumor types: primary colorectal cancer, locally recurrent colorectal cancer, colorectal cancer liver metastasis, colorectal cancer lung metastasis, colorectal cancer peritoneal metastasis, colorectal cancer bone metastasis, colorectal cancer multi-organ metastasis, primary liver cancer, primary lung cancer, primary peritoneal cancer, primary bone tumor.
No prior surgery or anti-tumor treatment at the time of enrollment assessment.
Subjects voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

Previous history of malignant tumors other than those within the inclusion criteria.
Pregnant or breastfeeding women.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Kolorektal kreft levermetastase
Primary colorectal cancer
Locally recurrent colorectal cancer
Colorectal cancer bone metastasis
Colorectal cancer lung metastasis
Colorectal cancer peritoneal metastasis
Primary lung cancer
Primary liver cancer
Colorectal cancer multi-organ metastasis
Primary bone tumor
Primary peritoneal cancer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Area Under the Receiver Operating Characteristic Curve (AUC) of the prediction models based on methylation, fragmentomics, and cfRNA data for local recurrence and distant metastasis localization in colorectal cancer Tidsramme: At baseline (at the time of study enrollment, prior to any surgical or anti-tumor treatment)	The AUC is calculated from the Receiver Operating Characteristic (ROC) curve to evaluate the discriminatory performance of the prediction model developed by use of methylation, fragmentomics, and cfRNA data. Model performance will be assessed on the validation cohort.	At baseline (at the time of study enrollment, prior to any surgical or anti-tumor treatment)

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Accuracy of the prediction models based on methylation, fragmentomics, and cfRNA data for colorectal cancer recurrence and metastasis localization Tidsramme: Baseline (at enrollment)	Accuracy is defined as the proportion of correctly predicted samples (true positives + true negatives) among the total number of samples in the validation cohort.	Baseline (at enrollment)
Sensitivity and specificity of individual omics technologies (methylation, fragmentomics, and cfRNA) Tidsramme: Baseline (at enrollment)	Comparison of predictive performance of three individual technical approaches for localization of recurrent and metastatic lesions.	Baseline (at enrollment)

Samarbeidspartnere og etterforskere

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

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)

29. juni 2026

Primær fullføring (Antatt)

28. juni 2027

Studiet fullført (Antatt)

28. juni 2027

Datoer for studieregistrering

Først innsendt

24. juni 2026

Først innsendt som oppfylte QC-kriteriene

30. juni 2026

Først lagt ut (Faktiske)

6. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)