a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

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

16666 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-28

Study Completion Date

2027-03-31

Brief Summary

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This study is a multi-center, case-control study aiming at developing and blinded testing machine learning-based multiple cancers early detection model by prospectively collecting blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis.

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Detailed Description

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Blood samples from newly diagnosed cancer patients and individuals without confirmed cancer diagnosis will be prospectively collected to identify cancer-specific circulating signals through integrative multi-omic analysis. Based on the comprehensive molecular profiling, a machine learning-driven model will be trained and blinded validated independent through a two-stage approach in clinically annotated individuals. Approximately 10327 cancer patients will be enrolled in this study and early-stage cancer patients will be enriched to improve the model sensitivity on distinguishing cancers with favorable prognosis. Approximately 6339 age and sex matched controls will be included in model development, which are volunteers without a cancer diagnosis after routine cancer screening tests.

Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case arm

Participants with newly diagnosed cancer of lung, breast, digestive tract, urinary tract and etc.

No interventions assigned to this group

Control arm

Participants without a cancer diagnosis after routine cancer screening tests.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 40-74 years old
* Clinically and/or pathologically diagnosed cancer
* No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures

* 40-74 years old
* Without confirmed cancer diagnosis
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria

* Pregnancy or lactating women
* Known prior or current diagnosis of other types of malignancies comorbidities
* Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers

* Pregnancy or lactating women
* Known prior or current diagnosis of other types of malignancies comorbidities
* Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to screen
* Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
* Unsuitable for this trial determined by the researchers

Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes