Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT

NCT ID: NCT04822792

Last Updated: 2021-06-02

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

UNKNOWN

Total Enrollment

11879 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-23

Study Completion Date

2023-06-30

Brief Summary

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PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, and healthy participants.

Detailed Description

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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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Cancer Arm

Participants with new diagnosis of cancer, from whom blood samples will be collected

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection test

Benign Diseases Arm

Participants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection test

Healthy Arm

Participants without known presence of malignancies or benign disease, from whom blood samples will be collected

Multi-cancer early detection test

Intervention Type DEVICE

Blood collection and multi-cancer early detection test

Interventions

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Multi-cancer early detection test

Blood collection and multi-cancer early detection test

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide a written informed consent
* 40-75 years old


* Confirmed diagnosis or suspicious cases of one of the 22 types of malignancies within 42 days prior to study blood draw
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw


* Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw
* No prior treatment of benign diseases prior to study blood draw


* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* No clinically significant finding by LDCT or ultrasound
* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
* No active hepatitis B or hepatitis C infection

Exclusion Criteria

* Inability to comply with study procedures
* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer


* Known prior diagnosis of malignancies
* Other current malignant diseases or multiple primary tumors
* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or diagnosis of a benign disease by histopathological assessments, or inability to characterize whether the lesion is malignant or benign
* Non-small-cell lung cancer patients with ground-class nodularity by radiological examination


* History of malignancies
* Current malignancies or precancerous lesions
* No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign


* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Clinically significant or uncontrolled comorbidities
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Wang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiachen Xu, M.D.

Role: CONTACT

+86-010-87788029

Shangli Cai, Ph.D.

Role: CONTACT

+86-021-61631938

Facility Contacts

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Jiachen Xu, M.D.

Role: primary

+86-10-87788029

Other Identifiers

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RSCD2020002

Identifier Type: -

Identifier Source: org_study_id

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