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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Invasive Cancer Healthy Volunteer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer patients

Patients who have diagnosed as invasive cancers

No interventions assigned to this group

Healthy volunteers

Subjects who have done cancer screening tests

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes