Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

NCT01292369 | Unknown

• 1 other identifier: RMB-0566.CTIL
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 2

Brief Summary

The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.

Conditions

Breast Cancer; Colon Cancer

Keywords

breath test; colon cancer; breast cancer

Outcome Measures

Primary Outcomes (1)

• System performance

  Sensitivity and specificity of NaNose system in diagnosing cancer

  10 months

Study Arms (4)

Breast cancer

Women diagnosed with breast cancer by a positive biopsy test after mammography.

Breast control

Women with negative biopsy result done due to a suspicious mammography exam.

Colon cancer

Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy.

Colon control

Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer.

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women coming for medical tests: 1. Women coming for a breast biopsy following a suspicious breast imaging result. 2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.

You may qualify if:

• Men and women attending Rambam medical center for either breast biopsy or colonoscopy.
• Suspicious finding on breast imaging requiring a biopsy.
• Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer.

You may not qualify if:

• Other known active malignancy.
• History of malignant disease and treatments.

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (2)

RAMBAM medical center

Haifa, 31096, Israel

RECRUITING

Carmel medical center

Haifa, Israel

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breath samples

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Zahava Galimidi, Dr.

CONTACT

972-4-8543684; z_gallimidi@rambam.health.gov.il

Yehuda Hovers, Prof.

CONTACT

972-4-8543608; y_chowers@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

IL (2)