Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for the Monitoring and Early Diagnosis of Malignant Solid Tumors

NCT02662621 | Completed

• 1 other identifier: 2014-A01638-39
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies shows that extracellular vesicles (named "exosomes") released by cancer cells exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal cells. These exosomes ("HSP70-exosomes") have a very important role in intercellular communication and have specific biological functions that can promote tumor progression. They are found in the different biological fluids such as blood and urine. We have developed a protocol able to isolate exosomes in blood and urine. We also demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those results strongly suggest that we can only identify exosomes with HSP70 at the membrane in patients with cancer. Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research. Because a cancer cell can releases a large amount of exosomes (several billion) and since its appearance, our approach will allow to earlier detect cancer with respect to the use of imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1 billion cells). The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis of patients with malignant solid tumor. In order to demonstrate this, the objective of the study is to study blood and urine samples from 60 subjects with a malignant tumor and 20 healthy subjects (witness).

Conditions

Cancer

Keywords

personalized care; early diagnosis; ovarian cancer; breast cancer; lung cancer; Early Detection; Cancer [E01.390.500]

Outcome Measures

Primary Outcomes (1)

• concentration of HSP70 exosomes in the blood and urine

  1 year

Study Arms (2)

ill patient

OTHER

Patient with a cancer disease

Other: blood samples; Other: Urine samples

Healthy volunter

OTHER

Subject without any cancer pathology

Other: blood samples; Other: Urine samples

Interventions

blood samples OTHER

Healthy volunter; ill patient

Urine samples OTHER

Healthy volunter; ill patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women newly diagnosed with either:
• Infiltrating non-metastatic breast cancer (positive or negative HER2 status or hormone therapy)
• Breast cancer with a first metastasis evolution (positive or negative HER2 status or hormone therapy).
• Ovarian cancer stage III and IV,
• Men and women who are newly diagnosed non-small cell lung cancer metastatic,
• Age ≥18 years
• Affiliation to a social security system,
• Signed Informed consent.

You may not qualify if:

• Patient with another synchronous tumor,
• Men with breast cancer,
• Positive HIV and / or HBV and / or HCV serology
• Patients unable to undergo a medical monitoring for geographical, social or psychological condition,
• Pregnant or nursing women,
• People enjoying a major protection system (including trusteeship and guardianship).
• Men or women aged 50-70 years (mean age of onset of various cancers in the study)
• Affiliation to a social security system,
• Signed Informed consent.
• history of cancer,
• Positive HIV and / or HBV and / or HCV serology
• Pregnant or nursing women,
• People enjoying a major protection system (including trusteeship and guardianship).

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead
• INSERM U866 Faculté de Médecine et Pharmacie: collaborator

Study Sites (1)

CGFL

Dijon, 21079, France

Location

Related Publications (1)

• Chanteloup G, Cordonnier M, Isambert N, Bertaut A, Marcion G, Garrido C, Gobbo J. Membrane-bound exosomal HSP70 as a biomarker for detection and monitoring of malignant solid tumours: a pilot study. Pilot Feasibility Stud. 2020 Mar 3;6:35. doi: 10.1186/s40814-020-00577-2. eCollection 2020.

  PMID: 32161659 DERIVED

MeSH Terms

Conditions

Neoplasms; Disease; Ovarian Neoplasms; Breast Neoplasms; Lung Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nicolas ISAMBERT, MD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: December 15, 2015
• Primary Completion: December 15, 2015
• Study Completion: April 8, 2019
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)