Gynecologic CancerNCT04903665
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I
An observational study of Gynecologic Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Multi-cancer early detection test
- Type of treatment
- Medical device
- How many people
- 495 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2021to 31 Dec 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of gynecologic malignancies and benign gynecologic diseases.
Who may be able to join
- Age 18 years or older
- Able to provide a written informed consent
- Confirmed diagnosis or highly suspicious cases of gynecologic malignancies
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Age 18 years or older
- Able to provide a written informed consent
- Confirmed diagnosis of benign gynecologic diseases
- No prior radical treatment of the benign diseases prior to study blood draw
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study
This study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.
- Conditions
- Gynecologic Cancer
- Being tested
- Multi-cancer early detection test
- Keywords
- gynecologic cancer, early detection, liquid biopsy, cell-free DNA
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 testing
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected. Receives: Device: Multi-cancer early detection test | |
| Benign Arm | Participants with new diagnosis of benign gynecologic diseases, 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,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.
Measured: 12 months
Secondary outcomes (2)
Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.
Measured: 12 months
Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start11 Feb 2021
- Primary completion22 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Responsible party
- Principal investigator, Xiaohua Wu MD, Fudan University
- Investigators
- Xiaohua Wu, M.D.&Ph.D, Principal investigator, Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903665
- Sponsor's protocol ID
- FDZL-2021002
- Status last verified
- Jul 2022
- First submitted
- 24 May 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecologic Malignancies Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT04903665
- Acronym / sponsor ID
- FDZL-2021002
- Conditions
- Gynecologic Cancer
- Keywords
- gynecologic cancer, early detection, liquid biopsy, cell-free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Bioengineering Ltd.
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 22 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 May 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.
This study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Device: Multi-cancer early detection testParticipants with new diagnosis of gynecologic cancers, from whom blood samples will be collected. |
| Benign Arm | – | Device: Multi-cancer early detection testParticipants with new diagnosis of benign gynecologic diseases, from whom blood samples will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of gynecologic malignancies and benign gynecologic diseases.
Key inclusion criteria (8 listed)
- Age 18 years or older
- Able to provide a written informed consent
- Confirmed diagnosis or highly suspicious cases of gynecologic malignancies
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Age 18 years or older
Key exclusion criteria (8 listed)
- 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
- Pregnancy or lactating women
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 testing | Device | Benign Arm, Cancer Arm |
Primary outcome
Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers.
Time frame: 12 months
2 secondary outcomes
Sensitivity and specificity of the multi-omics model in early detection of gynecologic cancers in different stages.
Time frame: 12 months
Sensitivity and specificity of the multi-omics model in early detection of different gynecologic cancer diseases
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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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.
Xiaohua Wu, M.D.&Ph.D principal investigator
Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
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 Gynecologic Cancer, run by Fudan University 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 8 inclusion and 8 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 28 Jul 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity,specificity and tissue of origin accuracy of the multi-omics model as early detection for gynecologic cancers. (time frame: 12 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 28 Jul 2022.