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

30 juni 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Metastatisk kolorektal cancer (CRC)

Studietyp

Observationell

Inskrivning (Beräknad)

586

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Kolorektal cancer levermetastaser
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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
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 Tidsram: 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)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Accuracy of the prediction models based on methylation, fragmentomics, and cfRNA data for colorectal cancer recurrence and metastasis localization Tidsram: 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) Tidsram: Baseline (at enrollment)	Comparison of predictive performance of three individual technical approaches for localization of recurrent and metastatic lesions.	Baseline (at enrollment)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

29 juni 2026

Primärt slutförande (Beräknad)

28 juni 2027

Avslutad studie (Beräknad)

28 juni 2027

Studieregistreringsdatum

Först inskickad

24 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)