CarcIno: Involvement of the Inositol-trisphosphate Receptor in Invasive or Migratory-type Breast Cancers

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT03107234

Collaborator

(none)

Enrollment

Location

35.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Breast cancer is the leading cause of female cancer and female death by cancer in France. Despite the improvement in early detection and therapeutic arsenal, the mortality of this cancer remains high with 11 886 deaths estimated in 2012. Breast cancer is most often a carcinoma born from the lobular or ductal epithelium and is classified In two main categories: non invasive and invasive. Invasive breast cancers account for 75% of the cases. They are usually ductal (75%) and more rarely lobular (25%). The cancer cells are then no longer circumscribed to the galactophoric canals or glands but have invaded neighboring tissues. If they are not treated in time, these cancers can then spread: the cancerous cells will then migrate either by the lymphatic vessels to reach the neighboring ganglia or through the blood vessels to give metastases in other tissues In the liver, lungs and bones). The mortality associated with breast cancer is not due to the growth of the primary tumor but rather to the occurrence of metastases. The study of the mechanisms leading to metastatic invasion (i.e. migration and invasion) is therefore of considerable importance. The development of metastases depends on the acquisition by the cancer cells of various capacities including that of being able to migrate, involving a remodeling of the cytoskeleton highly dependent on the intracellular calcium (Ca2 +) concentration. Several types of signals are able to induce mobilization of Ca2 + from the extracellular medium or endoplasmic reticulum (ER) reserves. At the intracellular level, some of these signals are generated by inositol (1,4,5) -trisphosphate (IP3) from the activation of G protein-coupled receptors or certain receptors with tyrosine kinase activity. Has been shown that the expression, activity and regulation of IP3R receptors (IP3Rs) are involved in the cancerous processes of many tissues, in particular in the phenomena of proliferation of breast cancer cells. Overall, altered expression and / or activity of IP3Rs can be used for the survival, growth, proliferation and migration of cancer cells.

In the laboratory, the investigator showed that regulation of the expression of subtype 3 (IP3R3) by 17β-estradiol (E2) is involved in the growth of the human mammary cancer line MCF-7. E2 triggers the release of Ca2 + in an IP3-dependent mechanism, while prolonged exposure to E2 leads to an increase in the expression of IP3R3. At the same time, the reduction in the expression of IP3R3 cancels the proliferative effect of E2 on MCF-7 cells. More recently, the investigator has established that IP3R3 regulates the proliferation of cells of the human MCF-7 mammary cancer cell line via a molecular and functional interaction with the Ca2 + -dependent BKCa potassium channel. The determination of IP3Rs, including subtype 3, as a mediator / marker of breast carcinogenesis appears to be a major clinical issue.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Inosine Triphosphatase	Other: Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Involvement of the Inositol-trisphosphate Receptor in Invasive or Migratory-type Breast Cancers

Actual Study Start Date :

Jul 20, 2015

Anticipated Primary Completion Date :

Jul 17, 2018

Anticipated Study Completion Date :

Jul 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patient with breast cancer requiring surgery to	Other: Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Arm

Intervention/Treatment

Patient with breast cancer requiring surgery to

Other: Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues

Outcome Measures

Primary Outcome Measures

Level of expression of IP3R3 defined by an immunohistochemical score [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CCI / CLI to be operated
Grade SBR 1, 2 or 3
Undifferentiated RE / PR status
HER2 status undifferentiated
Ki 67 indifferent
Metastatic or not
ADP axillary invaded or not
Major Patients

Exclusion Criteria:

CIC / CIL
Males

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT03107234

Other Study ID Numbers:

PI2015_843_0007

First Posted:

Apr 11, 2017

Last Update Posted:

Apr 11, 2017

Last Verified:

Apr 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 11, 2017