CancerSCHISMNCT05083494
Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.
An observational study of Cancer, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2021to Apr 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
- All sexes
- Adult, Older adult
Study population: Patients starting a cancer treatment, as part of marketing treatment (alone or in combination) in five type of cancer (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
Who may be able to join
- Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
- No contraindications to immunotherapy
- Non-pregnant patient
- Patient not opposed to participation in this study
Who cannot join
- HIV seropositivity
- Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures
Trial locations and contacts
1 site in 1 country.
Sebastien Salas, Professor contact
France1 site, 1 recruiting
- Recruiting
APHM
Marseille
Sebastien Salas, MD, sebastien.salas@ap-hm.fr
About this study
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.
The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
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 |
|---|---|---|
| Melanoma | Not described | |
| clear cell renal cancer | Not described | |
| Urothelial Carcinoma of the bladder | Not described | |
| squamous cell carcinomas of the head and neck | Not described | |
| non-small cell lung cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest of the plasmatic free circulating DNA (cfDNA)
The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate
Measured: At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start9 Apr 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2024 (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 Assistance Publique Hopitaux De MarseilleThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083494
- Sponsor's protocol ID
- 2020-048
- Acronym
- SCHISM
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.
- ClinicalTrials.gov ID
- NCT05083494
- Acronym / sponsor ID
- SCHISM / 2020-048
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Oct 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.
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.
The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Melanoma | – | – |
| clear cell renal cancer | – | – |
| Urothelial Carcinoma of the bladder | – | – |
| squamous cell carcinomas of the head and neck | – | – |
| non-small cell lung cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients starting a cancer treatment, as part of marketing treatment (alone or in combination) in five type of cancer (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
Key inclusion criteria (4 listed)
- Patients starting anti-PD1 immunotherapy as part of marketing authorization alone or in combination (melanoma, clear cell renal cancer, urothelial carcinomas of the bladder, squamous cell carcinomas of the head and neck and non-small cell lung cancer).
- No contraindications to immunotherapy
- Non-pregnant patient
- Patient not opposed to participation in this study
Key exclusion criteria (2 listed)
- HIV seropositivity
- Patient with psychiatric or other conditions that may compromise his or her ability to give non opposition or to follow study procedures
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
Interest of the plasmatic free circulating DNA (cfDNA)
Time frame: At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence
The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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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.
Sebastien Salas, Professor contact
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 Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 2 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 19 Oct 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 France. 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 Sebastien Salas, Professor (sebastien.salas@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interest of the plasmatic free circulating DNA (cfDNA) (time frame: At first evaluation, then 1 administration over 2 for 1 year then at 18 months and an additional sample will be taken at the time of recurrence). 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 19 Oct 2021.