Cutaneous LymphomaLYMPHOTEQNCT04520529
Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
A study testing Biologic Samples in people with Cutaneous Lymphoma, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lymphoma
- What is being tested?
- Biologic Samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2020to 30 Sep 2050
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old
- Informed consent signed by the patient
- Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria
Who cannot join
- Patient under guardianship or curatorship
- Lack of affiliation to social security
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.
- Conditions
- Cutaneous Lymphoma
- Being tested
- Biologic Samples
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic SamplesOther
- An additional punch from lesion skin as part of a skin biopsy performed as part of routine care.
- an additional blood sample will be collected for research during a blood test performed as part of the patient's routine care.
- In patients with clinical superficial lymphadenopathy or detected by imaging, and undergoing a superficial lymph node biopsy as part of the care, a core biopsy will be dedicated to research.
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary cutaneous lymphoma | Other | Not described Receives: Other: Biologic Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (3)
Progression free survival
Measured: 5 years
Progression free survival
Measured: 10 years
Overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start30 Sep 2020 (estimated)
- Primary completion30 Sep 2045 (estimated)
- Study completion30 Sep 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LymphomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520529
- Sponsor's protocol ID
- APHP190179
- Acronym
- LYMPHOTEQ
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prognostic Factors and New Therapeutic Targets in Cutaneous Lymphomas
- ClinicalTrials.gov ID
- NCT04520529
- Acronym / sponsor ID
- LYMPHOTEQ / APHP190179
- Conditions
- Cutaneous Lymphoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2045 (estimated)
- Study completion
- 30 Sep 2050 (estimated)
- First posted
- 20 Aug 2020 (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.
Cutaneous lymphomas are a heterogeneous group of extra-nodal lymphomas. The prognosis of cutaneous lymphomas is extremely variable from one subject to another. In the majority of cases, there is no cure for cutaneous lymphomas. Cutaneous lymphomas primarily affect the skin, and secondarily the blood, lymph nodes and possibly other organs. The discovery of new molecular prognostic factors will allow a better identification of patients at high risk of aggressive evolution and the implementation of a personalized therapeutic strategy. The identification of new therapeutic targets is necessary in order to develop new innovative treatments for cutaneous lymphomas.The primary objective is to identify novel molecular prognostic factors associated with 5-year overall survival in cutaneous lymphoma.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary cutaneous lymphoma | Other | Other: Biologic Samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> 18 years old
- Informed consent signed by the patient
- Suspicion of primary cutaneous lymphoma or confirmed lymphoma according to WHO/ISCL/EORTC criteria
Key exclusion criteria (2 listed)
- Patient under guardianship or curatorship
- Lack of affiliation to social security
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 |
|---|---|---|
| Biologic Samples* An additional punch from lesion skin as part of a skin biopsy performed as part of routine care. * an additional blood sample will be collected for research during a blood test performed as part of the patient's routine care. * In patients with clinical superficial lymphadenopathy or detected by imaging, and undergoing a superficial lymph node biopsy as part of the care, a core biopsy will be dedicated to research. | Other | Patients with primary cutaneous lymphoma |
Primary outcome
overall survival
Time frame: 5 years
3 secondary outcomes
Progression free survival
Time frame: 5 years
Progression free survival
Time frame: 10 years
Overall survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Biologic Samples in people with Cutaneous Lymphoma, run by Assistance Publique - Hôpitaux de Paris.
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 3 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: opening soon, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adèle DE MASSON (01 42 49 43 19, adele.demasson@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 years). 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 Aug 2020.