Head and Neck TumorsISOTOPENCT02864836
Study of Copper Isotope in Head and Neck Cancer
An observational study of Head and Neck Tumors, run by Lille Catholic University at 2 sites in France.
Trial summary
The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Tumors
- What is being tested?
- Samples collection
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 2 sitesFrance
- Study dates
- 15 May 2017to Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Three groups of patients will be involved in this study: * Patients with head and neck malignant tumors, * Patients with lymphoma, * Patients without tumoral ENT pathology
Who may be able to join
- Clinical diagnosis of head and neck malignant tumors or clinical diagnosis of head and neck lymphoma requiring sampling for diagnosis or clinical diagnosis of a non tumoral ENT pathology requiring surgery
Who cannot join
- Refusal of consent
- Inability to consent
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of the ISotopic Repartition of cOpper in Head and Neck TumOral and lymPhomatous pathologiEs
The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals.
The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis.
Read more
Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.
Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum.
Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors.
The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA).
Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors.
The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not.
In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.
- Conditions
- Head and Neck Tumors
- Being tested
- Samples collection
- Keywords
- Copper, isotopic distribution, cancer
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples collectionProcedure or surgery
5 samples collected for each patient (tumor biopsy, healthy tissue around the tumor, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins 4 samples for each patient (healthy tissue, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins
| Study group | Role | What they receive |
|---|---|---|
| Patients with head or neck cancer | Samples collection Receives: Procedure: Samples collection | |
| Patients with lymphoma | Samples collection Receives: Procedure: Samples collection | |
| Patients without tumoral pathology | Samples collection Receives: Procedure: Samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the different stable isotopes of copper in the various samples and groups
Measured: Baseline
Secondary outcomes (2)
Patient survival rate
Measured: at 5 years
mRNA expression level of proteins involved in copper metabolism assessed by Polymerase chain reaction (PCR)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start15 May 2017
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Normale Supérieure de Lyon
- Responsible party
- Sponsor
- Investigators
- Emmanuel Bartaire, PhD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864836
- Sponsor's protocol ID
- RT-14
- Acronym
- ISOTOPE
- Status last verified
- Jan 2020
- First submitted
- 9 Aug 2016
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the ISotopic Repartition of cOpper in Head and Neck TumOral and lymPhomatous pathologiEs
- ClinicalTrials.gov ID
- NCT02864836
- Acronym / sponsor ID
- ISOTOPE / RT-14
- Conditions
- Head and Neck Tumors
- Keywords
- Copper, isotopic distribution, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Ecole Normale Supérieure de Lyon
- Study start
- 15 May 2017 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- 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.
The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals.
The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis.
Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.
Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum.
Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors.
The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA).
Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors.
The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not.
In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with head or neck cancer | – | Procedure: Samples collectionSamples collection |
| Patients with lymphoma | – | Procedure: Samples collectionSamples collection |
| Patients without tumoral pathology | – | Procedure: Samples collectionSamples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups of patients will be involved in this study: * Patients with head and neck malignant tumors, * Patients with lymphoma, * Patients without tumoral ENT pathology
Key inclusion criteria (1 listed)
- Clinical diagnosis of head and neck malignant tumors or clinical diagnosis of head and neck lymphoma requiring sampling for diagnosis or clinical diagnosis of a non tumoral ENT pathology requiring surgery
Key exclusion criteria (3 listed)
- Refusal of consent
- Inability to consent
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Samples collection5 samples collected for each patient (tumor biopsy, healthy tissue around the tumor, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins 4 samples for each patient (healthy tissue, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins | Procedure or surgery | Patients with head or neck cancer, Patients with lymphoma, Patients without tumoral pathology |
Primary outcome
Ratio of the different stable isotopes of copper in the various samples and groups
Time frame: Baseline
2 secondary outcomes
Patient survival rate
Time frame: at 5 years
mRNA expression level of proteins involved in copper metabolism assessed by Polymerase chain reaction (PCR)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Head and Neck Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Emmanuel Bartaire, PhD principal investigator
GHICL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Tumors, run by Lille Catholic University at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Ratio of the different stable isotopes of copper in the various samples and groups (time frame: Baseline). 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 10 Jan 2020.