NCT01668238

Brief Summary

The purpose of this stage of study is to establish discriminant among healthy tissue, benign and malignant thyroid and breast tumors by fourier transform infrared spectrometry variables.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

August 7, 2012

Last Update Submit

August 14, 2012

Conditions

Thyroid TumorBreast Tumor

Keywords

Thyroid tumorBreast tumorFourier Transform Infrared SpectrometryTumor Diagnosis

Outcome Measures

Primary Outcomes (1)

  • pathologic findings

    1. In operation patients, discriminant between benign and malignant thyroid and breast tumors are established by fourier transform infrared spectrometry variables, and pathologic diagnoses are gold standard. 2. Between Patients and healthy volunteers, discriminant are established among thyroid and breast tumors and healthy tissues.

    12 months

Study Arms (3)

malignant tumor

Inpatients with malignant tumors of thyroid and breast

benign tumor

Inpatients with benign tumors of thyroid and breast

Healthy volunteers

Volunteers without thyroid or breast tumors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Hospitalized patients undergoing thyroid and breast tumor sugery; 2. Healthy volunteers

You may qualify if:

  • Patients undergoing thyroid and breast tumor surgery.
  • Informed consent form is signed.
  • An optical fibre and ATR probe can be applied to the operation field in process of open or laparoscopic surgery.
  • Male or female between the age of 18 to 80.
  • Patients can tolerate surgery and with non of these diseases: severe heart failure, liver failure, renal failure or respiratory failure.

You may not qualify if:

  • A state of emergency, such as Gastrointestinal bleeding, perforation, or acute obstruction.
  • unstable situation in operation, such as anesthetic accidents or intraoperative cerebral vascular accident.
  • From investigators' perspective patients do not suitable for the study
  • Informed consent form is signed.
  • No thyroid or breast cancer according to the professional judgment of general surgeon.
  • No thyroid or breast disease according to thyroid function tests and breast type B-ultrasonic test within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Zhi Xu, PhD MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi XU, PHD MD

CONTACT

86-10-82267331xuzhi123456@sohu.com

Long Cui

CONTACT

86-10-82267328cuilong1978@163.com

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 20, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 20, 2012

Record last verified: 2012-08

Locations

CN(1)