CancerCRYOTOXNCT03980977
Unusual Toxicity Induced by Radiotherapy
A study testing skin biopsy, tumor biopsy and blood sample in people with Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- skin biopsy, tumor biopsy and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2018to 27 Apr 2023
- Phase
- Interventional
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Child or teenager aged 2 to <18
- Man, Woman> 18 years old
- Patient with one of these situations:
- Unusual toxicity in progress or after radiotherapy
- Indication of radiotherapy and suspicion of abnormal pathways of response to ionizing radiation - constitutional (genetic disease) or acquired (systemic disease) - which may generate unusual radioinduced toxicity
- Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent
- Affiliation to a social security scheme.
Who cannot join
- Contraindication for skin and / or tumoral biopsy
- Contraindication for blood sample of 2.5 ml
- Persons deprived of liberty or under supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy
In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.
- Conditions
- Cancer
- Being tested
- skin biopsy, tumor biopsy, blood sample
- Keywords
- unusual toxicity, radiosensitivity, radiotherapy, fibroblast cell, indirect immunofluorescence test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
skin biopsy will be taken under local anesthesia using a patch of lidocaine and prilocaine. In practice, during the skin biopsy, the skin must be cleaned with chlorhexidine or alcohol, to the exclusion of any other antiseptic. The biopsy will preferably be done with a dermatome (or "punch", 12 G).
tumor biopsyOther
an additional tumor sample will be taken during programmed diagnostic procedure.
blood sampleOther
blood sample will be taken for biological collection
| Study group | Role | What they receive |
|---|---|---|
| skin and/or tumor Biopsy and blood sample | Other | Not described Receives: Other: skin biopsy; Other: tumor biopsy; Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin fibroblast radiosensitivity
The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence
Measured: 2 to 3 months after skin biopsy
Secondary outcomes (1)
tumor cells radiosensitivity
The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence
Measured: 2 to 3 months after tumor biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start4 May 2018
- Primary completion26 Apr 2023
- Study completion27 Apr 2023
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980977
- Sponsor's protocol ID
- 2017 A00266-47
- Acronym
- CRYOTOX
- Status last verified
- Nov 2023
- First submitted
- 3 Jun 2019
- Last updated
- 30 Nov 2023
- 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 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Biological Samples for Stydy of Unusual Toxicity Induced by Radiotherapy
- ClinicalTrials.gov ID
- NCT03980977
- Acronym / sponsor ID
- CRYOTOX / 2017 A00266-47
- Conditions
- Cancer
- Keywords
- unusual toxicity, radiosensitivity, radiotherapy, fibroblast cell, indirect immunofluorescence test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 10 Jun 2019 (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.
In order to evaluate the physiopathological knowledge of the different pathological manifestations associated with individual radiosensitivity, it seems essential to carry out this pilot study. It has agglomerated homogeneous tissue samples to identify new biomarkers for patient diagnosis and follow-up, and may predict the therapeutic response. These knowledge will help to treatment customization.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skin and/or tumor Biopsy and blood sample | Other | Other: skin biopsy, Other: tumor biopsy, Other: blood sample |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Child or teenager aged 2 to <18
- Man, Woman> 18 years old
- Patient with one of these situations:
- Patient information and informed consent signed by the patient. For children and teenager : information to parents and obtaining informed consent
- Affiliation to a social security scheme.
Key exclusion criteria (3 listed)
- Contraindication for skin and / or tumoral biopsy
- Contraindication for blood sample of 2.5 ml
- Persons deprived of liberty or under supervision
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 |
|---|---|---|
| skin biopsyskin biopsy will be taken under local anesthesia using a patch of lidocaine and prilocaine. In practice, during the skin biopsy, the skin must be cleaned with chlorhexidine or alcohol, to the exclusion of any other antiseptic. The biopsy will preferably be done with a dermatome (or "punch", 12 G). | Other | skin and/or tumor Biopsy and blood sample |
| tumor biopsyan additional tumor sample will be taken during programmed diagnostic procedure. | Other | skin and/or tumor Biopsy and blood sample |
| blood sampleblood sample will be taken for biological collection | Other | skin and/or tumor Biopsy and blood sample |
Primary outcome
skin fibroblast radiosensitivity
Time frame: 2 to 3 months after skin biopsy
The number of residual double strand break at 24 hours (number of 53BP1 foci) after a dose of 2 Gy will be quantified with indirect immunofluorescence
1 secondary outcome
tumor cells radiosensitivity
Time frame: 2 to 3 months after tumor biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy, tumor biopsy and blood sample in people with Cancer, run by Institut de Cancérologie de Lorraine 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 30 Nov 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
skin fibroblast radiosensitivity (time frame: 2 to 3 months after skin biopsy). 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 30 Nov 2023; AzTrials last refreshed its copy on 31 Oct 2026.