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Prospective Study for the Development, Validation and Confirmation of a Multi-Cancer Early Detection Platform Through Whole-Genome Sequencing Analysis of Circulating DNA in Cancer and Non-Cancer Subjects

13 mai 2026 mis à jour par: Chang Gon Kim

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. This study was designed to establish a clinical and molecular database using circulating DNA from both cancer patients and non-cancer participants, advance and validate an artificial intelligence platform capable of detecting various types of cancer at an early stage, and evaluate its performance.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Description détaillée

Written informed consent will be obtained from each participant, and screening will begin after obtaining consent according to the study's inclusion and exclusion criteria.

The informed consent form (ICF) approved by each institution's IRB/EC must be used, and a copy of the signed ICF will be provided to the participant.

For participants who meet the eligibility criteria (meeting all inclusion criteria and none of the exclusion criteria), 20 mL of peripheral whole blood will be collected via standard venipuncture; the time of blood collection will be considered the time of study enrollment.

The collected 20 mL of blood will be divided into two Streck tubes (approximately 10 mL per tube) and must be handled, stored, and submitted according to the most recent laboratory manual.

Cancer participants: Blood will be collected before initiation of any treatment (surgery, chemotherapy, etc.) following cancer diagnosis.

Non-cancer participants: Blood will be collected during routine health examinations.

For domestic (Korean) cases, collected specimens should be stored at room temperature and transported as whole blood (without centrifugation) to the location designated by the sponsor by the following day after collection.

Clinical data of participants (cancer patients and healthy adults)-including sex, age, race, medical history, laboratory tests, imaging, and pathology results-will be collected in the electronic case report form (eCRF).

Type d'étude

Observationnel

Inscription (Estimé)

6000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Chang Gon Kim
Numéro de téléphone: +82-2-2228-8130
E-mail: inspector@yuhs.ac

Lieux d'étude

Corée du Sud
- - Seoul, Corée du Sud, 03722
    - Recrutement
    - Yonsei Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Cancer patients 5,000, Healthy volunteers: 1,000

La description

Inclusion Criteria:

Adults aged 19 years or older
Individuals who understand the study and voluntarily provide informed consent.
(only for cancer participants) Participants with newly diagnosed solid tumors (Stage I-IV, including brain tumors) or hematologic malignancies who:
- Have a histologically confirmed diagnosis (including bone marrow biopsy), or
- Are highly suspected of having cancer based on clinical and/or radiologic evaluation and are scheduled for surgical resection after blood collection; and
- Have not yet initiated any treatment (chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, surgical resection, etc.).
(only for non-cancer participants) Individuals with no prior history of cancer.
(only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

Exclusion Criteria:

Pregnancy (self-reported pregnancy status).
Individuals for whom blood collection is deemed difficult by the investigator.
Individuals with a history of infection with HIV, HTLV, or syphilis.
(only for non-cancer participants) Individuals diagnosed with another malignancy within the past 5 years (exceptions: non-melanoma skin cancer, in-situ malignancies, thyroid cancer, and cervical intraepithelial neoplasia treated with curative intent).
(only for non-cancer participants) Individuals with cancer of unknown primary origin.
(only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
Volontaires en bonne santé
Cancer patients

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test. Délai: Assessed up to 36 months	Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated to evaluate its diagnostic performance for cancer detection. Sensitivity is defined as the proportion of participants with cancer who test positive on the MCED assay, while specificity is defined as the proportion of participants without cancer who test negative. Positive predictive value and negative predictive value will be calculated based on the proportion of true-positive and true-negative results among all positive and negative test results, respectively.	Assessed up to 36 months

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
To evaluate the accuracy of tumor of origin prediction of MCED test. Délai: Assessed up to 36 months	To assess whether tumor of origin predictions from the MCED test are concordant with clinically diagnosed tumor types. The numbers of concordant and discordant cases will be summarized to evaluate prediction accuracy.	Assessed up to 36 months
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test by stage. Délai: Assessed up to 36 months	Sensitivity, specificity, positive predictive value, and negative predictive value of the MCED test will be calculated according to cancer stage to evaluate stage-specific diagnostic performance.	Assessed up to 36 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chang Gon Kim

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 octobre 2024

Achèvement primaire (Estimé)

13 octobre 2029

Achèvement de l'étude (Estimé)

13 octobre 2032

Dates d'inscription aux études

Première soumission

20 novembre 2025

Première soumission répondant aux critères de contrôle qualité

13 mai 2026

Première publication (Réel)

20 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)