Multiple Primary CancersPhase 2NCT05164510
Value of ctDNA in the Treatment of Multiple Primary Cancers
A Phase 2 study testing ct-DNA guided therapy in people with Multiple Primary Cancers, run by Fudan University at 1 site in China.
Trial summary
This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood circulating tumor DNA (CT-DNA) gene profile of patients with multiple primary tumors (MPC) and to evaluate the exploratory study for guiding drug selection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Primary Cancers
- What is being tested?
- ct-DNA guided therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to Sep 2023
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were assessed to meet the diagnostic criteria for multiple primary tumors : each tumor had to be invasive histologically
- Each tumor has its own pathologic appearance
- Each tumor occurs in a different organ and must exclude metastasis or recurrence
- progress or failure after treatment on a standard regimen for related primary cancer
- regardless of gender, between 18 and 75
- The Eastern Cancer Collaboration Group (ECOG) scored 0 ~ 1 in physical condition (PS)
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- has an estimated survival of more than three months;
- During 7 days (including 7 days) before screening, the laboratory test data were obtained: neutrophil count ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90g/L (no transfusion within 14 days), serum total bilirubin ≤1.25 times normal upper limit (ULN);alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤ 2.5 x ULN (≤5x ULN in patients with liver metastasis);Serum creatinine ≤1.25 x ULN and creatinine clearance ≥60ml/min;
- Participating subjects (or their legal representative/guardian) had to sign an informed consent form saying they understood the study's objectives, understood the required procedures, and were willing to participate in the study.
Who cannot join
- have standard treatment for metastatic disease;
- Participants were given any experimental or antineoplastic drugs during the first four weeks of enrollment;
- Either symptomatic brain or meningeal metastasis (unless the patient is treated for something)At 6 months, imaging results were negative within 4 weeks prior to study entry and tumor-related clinical symptoms were stable at study entry);
- clinically active bleeding;
- Women who are pregnant or breastfeeding;Those who are fertile but do not take adequate contraceptive measures;
- addicted to alcohol or drugs;
- either major organ failure or other serious illness, including interstitial pneumonia, clinically relevant coronary disease, cardiovascular disease, or having myocardial infarction, congestive heart failure, unstable angina, pronounced pericardial effusion, or unstable arrhythmia in the first 6 months of the study;
- A history of severe neurological or mental illness;Severe infection;Active disseminated intravascular coagulation or other comorbidities that, in the investigator's judgment, seriously compromised the patient's safety or prevented the patient from completing the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cencer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Exploratory Study on Gene Profiling of Circulating Tumor DNA（ctDNA） of Multiple Primary Cancers （MPC） and Its Value in Guidance of Clinical Choice of Drugs
This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood circulating tumor DNA (CT-DNA) gene profile of patients with multiple primary tumors (MPC) and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death.Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).
Read the detailed description
This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood CT-DNA gene profile of patients with multiple primary tumors and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death. Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).
- Conditions
- Multiple Primary Cancers
- Being tested
- ct-DNA guided therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct-DNA guided therapyGenetic
Also called treatment according to ct-DNA results
treatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended.
| Study group | Role | What they receive |
|---|---|---|
| ct-DNA test in MPC | Experimental | treatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended. Receives: Genetic: ct-DNA guided therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with aberrant CT-DNA gene profile
Measured: 8 months
Secondary outcomes (1)
number of patients with drugable CT-DNA gene profile
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary CancersStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164510
- Sponsor's protocol ID
- Fudan CMP-001
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- 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 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Gene Profiling of Circulating Tumor DNA（ctDNA） of Multiple Primary Cancers （MPC） and Its Value in Guidance of Clinical Choice of Drugs
- ClinicalTrials.gov ID
- NCT05164510
- Acronym / sponsor ID
- Fudan CMP-001
- Conditions
- Multiple Primary Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 20 Dec 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 trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood circulating tumor DNA (CT-DNA) gene profile of patients with multiple primary tumors (MPC) and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death.Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).
Detailed description
This trial is a single-center, prospective, exploratory study.The objective is to study the peripheral blood CT-DNA gene profile of patients with multiple primary tumors and to evaluate the exploratory study for guiding drug selection. Patients with multiple primary tumors who met the inclusion criteria and did not meet the exclusion criteria will be enrolled in this study. CtDNA test will be used for CT-DNA gene profile study, and whether the test results can guide drug selection will be evaluated.The expected enrollment time is 12 months, and clinical observation is performed until disease progression and patient death. Additional CT-DNA tests will be performed as the disease progresses (2 cT-DNA tests in total).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ct-DNA test in MPC | Experimental | Genetic: ct-DNA guided therapytreatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were assessed to meet the diagnostic criteria for multiple primary tumors : each tumor had to be invasive histologically
- Each tumor has its own pathologic appearance
- Each tumor occurs in a different organ and must exclude metastasis or recurrence
- progress or failure after treatment on a standard regimen for related primary cancer
- regardless of gender, between 18 and 75
Key exclusion criteria (8 listed)
- have standard treatment for metastatic disease;
- Participants were given any experimental or antineoplastic drugs during the first four weeks of enrollment;
- Either symptomatic brain or meningeal metastasis (unless the patient is treated for something)At 6 months, imaging results were negative within 4 weeks prior to study entry and tumor-related clinical symptoms were stable at study entry);
- clinically active bleeding;
- Women who are pregnant or breastfeeding;Those who are fertile but do not take adequate contraceptive measures;
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 |
|---|---|---|
| ct-DNA guided therapyAlso: treatment according to ct-DNA resultstreatment according to ct-DNA results:For Patients with abnormal gene changes of corresponding targeted drugs are recommended to use corresponding targeted therapy or immunotherapy drugs;For Patients without abnormal gene changes of corresponding targeted drugs, Treatment of Physician's Choice (TPC) is recommended. | Genetic | ct-DNA test in MPC |
Primary outcome
number of patients with aberrant CT-DNA gene profile
Time frame: 8 months
1 secondary outcome
number of patients with drugable CT-DNA gene profile
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ct-DNA guided therapy in people with Multiple Primary Cancers, 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 9 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 20 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhiguo Luo, MD (02164175590, luozhiguo88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with aberrant CT-DNA gene profile (time frame: 8 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 20 Dec 2021.