CancerPRESCIENTNCT04822792
Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT
An observational study of Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 11,879 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Eligible participants will be re recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancies or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Inclusion Criteria for Non-tumor (Healthy) Arm Participants:
- 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 for Non-tumor (Healthy) Arm Participants:
- Prior or ongoing treatment of cancer within 3 years prior to study blood draw
- Clinically significant or uncontrolled comorbidities
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jiachen Xu, M.D., +86-10-87788029, XJCwelcome@126.com
Jie Wang, M.D., Ph.D
About this study
Official title: Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational Study
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.
- Conditions
- Cancer
- Being tested
- Multi-cancer early detection test
- Keywords
- Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-cancer early detection testDevice
Blood collection and multi-cancer early detection test
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with new diagnosis of cancer, from whom blood samples will be collected Receives: Device: 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 Receives: Device: Multi-cancer early detection test | |
| Healthy Arm | Participants without known presence of malignancies or benign disease, from whom blood samples will be collected Receives: Device: Multi-cancer early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers
Measured: 22 months
Secondary outcomes (3)
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases
Measured: 22 months
Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants
Measured: 22 months
Sensitivity and specificity of early detection of cancer in different stages
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start23 Mar 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 11,879 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jie Wang, M.D., Ph.D, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822792
- Sponsor's protocol ID
- RSCD2020002
- Acronym
- PRESCIENT
- Status last verified
- May 2021
- First submitted
- 29 Mar 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04822792
- Acronym / sponsor ID
- PRESCIENT / RSCD2020002
- Conditions
- Cancer
- Keywords
- Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,879 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Device: Multi-cancer early detection testParticipants with new diagnosis of cancer, from whom blood samples will be collected |
| Benign Diseases Arm | – | Device: Multi-cancer early detection testParticipants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected |
| Healthy Arm | – | Device: Multi-cancer early detection testParticipants without known presence of malignancies or benign disease, from whom blood samples will be collected |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be re recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancies or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-cancer early detection testBlood collection and multi-cancer early detection test | Device | Benign Diseases Arm, Cancer Arm, Healthy Arm |
Primary outcome
Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers
Time frame: 22 months
3 secondary outcomes
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases
Time frame: 22 months
Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants
Time frame: 22 months
Sensitivity and specificity of early detection of cancer in different stages
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Wang, M.D., Ph.D principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiachen Xu, M.D. (+86-010-87788029, XJCwelcome@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.