A Biomarker Exploration Study for Predicting Localization of Recurrence and Metastasis in Colorectal Cancer (PROBE Study) (PROBE)
30. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
586
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yanhong Gu, PhD
- Telefonnummer: +025-68307881
- E-mail: YanhongGu@njmu.edu.cn
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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Kolorektal cancer levermetastase
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Primary colorectal cancer
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Locally recurrent colorectal cancer
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Colorectal cancer bone metastasis
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Colorectal cancer lung metastasis
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Colorectal cancer peritoneal metastasis
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Primary lung cancer
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Primary liver cancer
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Colorectal cancer multi-organ metastasis
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Primary bone tumor
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Primary peritoneal cancer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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)
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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.
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At baseline (at the time of study enrollment, prior to any surgical or anti-tumor treatment)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Accuracy of the prediction models based on methylation, fragmentomics, and cfRNA data for colorectal cancer recurrence and metastasis localization
Tidsramme: Baseline (at enrollment)
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Accuracy is defined as the proportion of correctly predicted samples (true positives + true negatives) among the total number of samples in the validation cohort.
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Baseline (at enrollment)
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Sensitivity and specificity of individual omics technologies (methylation, fragmentomics, and cfRNA)
Tidsramme: Baseline (at enrollment)
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Comparison of predictive performance of three individual technical approaches for localization of recurrent and metastatic lesions.
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Baseline (at enrollment)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
29. juni 2026
Primær færdiggørelse (Anslået)
28. juni 2027
Studieafslutning (Anslået)
28. juni 2027
Datoer for studieregistrering
Først indsendt
24. juni 2026
Først indsendt, der opfyldte QC-kriterier
30. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-SR-422
Plan for individuelle deltagerdata (IPD)
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