Gynecologic CancerNCT06001099
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
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 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 onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 2,935 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to 31 Dec 2024
- 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
- Healthy volunteers accepted
- 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 healthy controls
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 within 42 days prior to blood collection
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Able to provide a written informed consent.
- Able to provide sufficient and qualified blood samples for study tests.
- No cancer related symptoms within 30 days prior to study screening.
- Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.
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.
- previous history of malignant tumor;
- precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;
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- unknown or insufficient to determine the nature of the lesion by histopathological reports;
- Insufficient qualified blood sample for study test.
- During pregnancy or lactation.
- Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
- Recipient of blood transfusion within 30 days prior to study blood draw.
- Recipient of anti-infectious therapy within 14 days prior to study blood draw.
- Have received or are undergoing curative cancer treatment within three years prior to study screening.
- With autoimmune or other diseases with severe comorbidities.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, 200032
Hao Wen, MD.&PHD, +86-021-64175590 ext. 81007, wenhao_fdc@163.com
Yuzi Zhang, M.D, +86-021-60293798, Z_Zhangyuzi@163.com
About this study
Official title: Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
This study is a prospective study aimed to 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 2935 female participants, including participants with gynecologic cancers patients and healthy participants.
- Conditions
- Gynecologic Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer arm | Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected | |
| Healthy arm | Participants without a known cancer or certain benign disease, from whom blood samples will be collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
Measured: 24 months
Secondary outcomes (2)
To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.
Measured: 24months
To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start22 Feb 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (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
- 2,935 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Principal investigator, Zhong Zheng MD, Fudan University
- Investigators
- Xiaohua Wu, MD.&PHD, Principal investigator, Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001099
- Sponsor's protocol ID
- RSCD2021002
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study
- ClinicalTrials.gov ID
- NCT06001099
- Acronym / sponsor ID
- RSCD2021002
- Conditions
- Gynecologic Cancer
- Keywords
- gynecologic cancer, early detection, liquid biopsy, cell-free DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,935 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Aug 2023 (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 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 2935 female participants, including participants with gynecologic cancers patients and healthy participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer arm | – | –Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected |
| Healthy arm | – | –Participants without a known cancer or certain benign disease, from whom blood samples will be collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- 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 healthy controls
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 within 42 days prior to blood collection
- No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw
- Able to provide a written informed consent.
Key exclusion criteria (14 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.
- previous history of malignant tumor;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
Time frame: 24 months
2 secondary outcomes
To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.
Time frame: 24months
To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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.
Xiaohua Wu, MD.&PHD 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 14 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 29 Sep 2023. 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 Hao Wen, MD.&PHD (+86-021-64175590 ext. 81007, wenhao_fdc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies (time frame: 24 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 29 Sep 2023.