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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 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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).

Studietyp

Observationell

Inskrivning (Beräknad)

6000

Kontakter och platser

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

Studiekontakt

Studieorter

  • Sydkorea
      • Seoul, Sydkorea, 03722
        • Rekrytering
        • Yonsei Cancer Center

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

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

  1. Adults aged 19 years or older
  2. Individuals who understand the study and voluntarily provide informed consent.

  3. (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.).
  4. (only for non-cancer participants) Individuals with no prior history of cancer.
  5. (only for non-cancer participants) Individuals scheduled to undergo chest and/or abdominal CT or MRI imaging.

Exclusion Criteria:

  1. Pregnancy (self-reported pregnancy status).
  2. Individuals for whom blood collection is deemed difficult by the investigator.
  3. Individuals with a history of infection with HIV, HTLV, or syphilis.
  4. (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).
  5. (only for non-cancer participants) Individuals with cancer of unknown primary origin.
  6. (only for non-cancer participants) Individuals with synchronous or metachronous multiple primary cancers.

Studieplan

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

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Friska volontärer
Cancer patients

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate sensitivity, specificity, positive predictive value, negative predictive value of MCED test.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To evaluate the accuracy of tumor of origin prediction of MCED test.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Chang Gon Kim

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 (Faktisk)

14 oktober 2024

Primärt slutförande (Beräknad)

13 oktober 2029

Avslutad studie (Beräknad)

13 oktober 2032

Studieregistreringsdatum

Först inskickad

20 november 2025

Först inskickad som uppfyllde QC-kriterierna

13 maj 2026

Första postat (Faktisk)

20 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 4-2024-1061

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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