Study of Copper Isotope in Head and Neck Cancer (ISOTOPE)

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.

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 Overview

• Status: Unknown
• Conditions: Head and Neck Tumors
• Intervention / Treatment: Procedure: Samples collection

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • GHICL
  • Lyon, France, 69622
    • ENS Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Refusal of consent

Inability to consent

Pregnant or breastfeeding women

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with head or neck cancer; Samples collection	Procedure: Samples collection; 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
Patients with lymphoma; Samples collection	Procedure: Samples collection; 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
Patients without tumoral pathology; Samples collection	Procedure: Samples collection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ratio of the different stable isotopes of copper in the various samples and groups	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient survival rate	at 5 years
mRNA expression level of proteins involved in copper metabolism assessed by Polymerase chain reaction (PCR)	baseline

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Collaborators: Ecole Normale Supérieure de Lyon
• Investigators: Principal Investigator: Emmanuel Bartaire, PhD, GHICL

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ANTICIPATED): November 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (ESTIMATE): August 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: cancer; Copper; isotopic distribution
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: RT-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO