Study of Copper Isotope in Head and Neck Cancer

Head and Neck Tumors Clinical Trial

— ISOTOPE  

Official title:

Study of the ISotopic Repartition of cOpper in Head and Neck TumOral and lymPhomatous pathologiEs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02864836
• Other study ID #: RT-14
• Status: Active, not recruiting
• Start date: May 15, 2017
• Est. completion date: November 2021

Study information

• Verified date: January 2020
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head and Neck Tumors

Intervention

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

Locations

Country	Name	City	State
France	GHICL	Lille
France	ENS Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Ecole Normale Supérieure de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of the different stable isotopes of copper in the various samples and groups		Baseline
Secondary	Patient survival rate		at 5 years
Secondary	mRNA expression level of proteins involved in copper metabolism assessed by Polymerase chain reaction (PCR)		baseline