Electronic Nose and Fetal Chromosomal Disorders

Examining the Ability of Electronic Nose in Detecting Fetal Chromosomal Disorders

"electronic nose"- the tiny sensors, will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

Study Overview

• Status: Unknown
• Conditions: Detecting Abnormal Fetal Karyotype by the Electronic Nose
• Intervention / Treatment: Other: observational study done only in women candidate for amniocentesis

Detailed Description

The biochemical engineering department had developed a device called "electronic nose" that can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit.. Thanks to their small size, electrical, physical and chemical properties, the sensitive sensors smell and identified changes in composition of the materials that characterize various diseases including kidney disease and asthma.

The electronic nose was developed by Professor Haick from the Technion. The main concept of the device is testing and characterization a trace amounts of substances in the air with the help of nana-technology sensors the idea is revolutionary and would allow the diagnosis of different diseases, like cancer, by exhaling air into the device.

The test is simple and not complicated to perform ,the examiner inhale air into a bag which connected to the "electronic nose". The molecules of the patient's breath will be tied to sensors and transmit an electrical signal to computer chip.

After processing the data the "electronic nose "can distinguish between normal cells and pathological cells.

Hypothesis: the tiny sensors ("electronic nose") will smell and detect the changes in the sample of abnormal fetal karyotype, and fluid that will be confirmed by amniocentesis.

• Study Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

A prospective study that includes pregnant women candidates for amniocentesis between 17-33 gestational weeks

Description

Inclusion Criteria:

• Pregnant women candidates for amniocentesis
• 17-33 gestational weeks

Exclusion Criteria:

• women that refuse to participate in the research
• women older than 45 or less than 16

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women candidates for amniocentesis; pregnant women candidates for amniocentesis between 17-33 gestational weeks	Other: observational study done only in women candidate for amniocentesis; As a part of routine test in women with obstetrical indication for amniocentesis, we take 30 cc of amniotic fluid. only additional 3 ml of the amniotic fluid are needed for examination by electronic sensors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examining the ability of the electronic nose in detecting abnormal fetal karyotype	the electronic nose can detect various diseases Including cancer and asthma on basis of evaporable substances. The device simulates the human nose ", which includes an array of tiny sensors connected to nanometric sizes electronic calculating unit. 30 cc of amniotic fluid are part of routine tests and the rest of the amount (3 ml) is intended for research, this sample will be saved in cooling (-20) and subsequently transferred to the Technion, for examination by electronic sensors. The amount of amniotic fluid designed for research is a minimal amount and will not hurt the fetus. At the end of the study following the data processing, we will be able to appreciate the effectiveness of the electronic nose in diagnosing fetal chromosomal disorders.	3 years

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: electronic nose; abnormal fetal karyotype
• Additional Relevant MeSH Terms: Congenital Abnormalities; Genetic Diseases, Inborn; Chromosome Disorders
• Other Study ID Numbers: 0200-15-RMB