NCT00868504

Brief Summary

Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

March 24, 2009

Last Update Submit

September 29, 2009

Conditions

Carcinoma, Undifferentiated

Keywords

GI tractTumorsTemperatures

Outcome Measures

Primary Outcomes (1)

  • Difference of temperature between tumors and adjacent tissues

    immediate

Study Arms (1)

examined by endoscopy

Patients, examined by endoscopy, being screened for GI tract tumors

Other: no intervention

Interventions

no interventionOTHER

no intervention

examined by endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo endoscopy or colonoscopy.

You may qualify if:

  • consenting adults

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

  • Stefanadis C, Chrysohoou C, Panagiotakos DB, Passalidou E, Katsi V, Polychronopoulos V, Toutouzas PK. Temperature differences are associated with malignancy on lung lesions: a clinical study. BMC Cancer. 2003 Jan 6;3:1. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.

    PMID: 12515579BACKGROUND

MeSH Terms

Conditions

CarcinomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Arie Orenstein, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arie Orenstein, Prof.

CONTACT

+97235303114gidi.arbel@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

IL(1)