Study of Copper Isotope in Head and Neck Cancer

NCT02864836 | Unknown

• 1 other identifier: RT-14
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Head and Neck Tumors

Keywords

Copper; isotopic distribution; cancer

Outcome Measures

Primary Outcomes (1)

• Ratio of the different stable isotopes of copper in the various samples and groups

  Baseline

Secondary Outcomes (2)

• Patient survival rate

  at 5 years

• mRNA expression level of proteins involved in copper metabolism assessed by Polymerase chain reaction (PCR)

  baseline

Study Arms (3)

Patients with head or neck cancer

Samples collection

Procedure: Samples collection

Patients with lymphoma

Samples collection

Procedure: Samples collection

Patients without tumoral pathology

Samples collection

Procedure: Samples collection

Interventions

Samples collection PROCEDURE

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 head or neck cancer; Patients with lymphoma; Patients without tumoral pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Refusal of consent
• Inability to consent
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Lille Catholic University: lead
• Ecole Normale Supérieure de Lyon: collaborator

Study Sites (2)

GHICL

Lille, 59000, France

Location

ENS Lyon

Lyon, 69622, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Urine Saliva cancer tissue healthy tissue

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Emmanuel Bartaire, PhD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: May 15, 2017
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)