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NCT Number: NCT06231953

A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.

The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yonsei Cancer Center, Yonsei Univ. College of Medicine

Seoul, South Korea

Location status: Recruiting

Location contact

Joohyuk Sohn

CONTACT

[email protected]

+82-2-2228-8135

About this study

AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.

The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.

The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 19 years or older
  • Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
  • Subjects who have agreed to provide clinical information and blood samples
  • Subjects who have agreed for the storage and secondary use of residual blood samples for research
  • Subjects who have understood the study and are able to provide a written informed consent

Exclusion criteria

  • Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
  • Subjects with a history of HIV, HTLV, or Syphilis infection
  • Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
  • Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)

Treatment and study plan

Primary outcomes

  1. Diagnosis of invasive cancer, assessed by positive predictive value and negative predictive value

    Time frame: 36 months

  2. Accuracy of prediction for the origin of cancer, assessed by concordance rate

    Time frame: 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Joohyuk Sohn

CONTACT

[email protected]

+82-2-2228-8135

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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