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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03483974
Other study ID # 201701068B0
Secondary ID
Status Recruiting
Phase
First received March 24, 2018
Last updated March 24, 2018
Start date August 1, 2017
Est. completion date September 30, 2018

Study information

Verified date March 2018
Source Chang Gung Memorial Hospital
Contact Chih-Shou Chen
Phone +886975353211
Email cgmh5093@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background Information With the advance in cancer biology, we realize that malignant neoplasm is related with different biological patterns in metabolome and microbiota. Because of the progress in optical spectrometry, it has become possible to evaluate whole visible and innon-visiable absorptive spectrum in human specimens, which may enable detection of minor changes in compound related with altered metabolome and microbiota. We hope to utilize hyperspectral imagingthis spectrum technology to reveal the possible clues of neoplasm for early stage detection

Material and Methods This research intended to enroll one hundred patients into the study. This includes patients with positive stool or urine analysis admitted for workup of colorectal cancer. We will scan the stool and urine with hyperspectral imaging sensoroptical spectrometer, which utilize multichannel charge-coupled device and InGaAs array to analyze the full spectrum of light patterns. The image pattern will be stored and used to linked final diagnosis. Absorption, scattering, and reflection spectra are expected for analysis. Follow up analysis after cancer staging will be used for lowering background noise in all spectra.

Expected Results We expect that there will be specific spectral pattern in stool of colorectal cancer patients, which may be related with cancer staging and different from those in patients without malignancy. Difference in spectra will lead to discovery of new biomarker for colorectal cancer and related diseases. The optic spectra pattern of stool and urine may assist early diagnosis and staging of different malignancies


Description:

Background Information With the advance in cancer biology, we realize that malignant neoplasm is related with different biological patterns in metabolome and microbiota. Because of the progress in optical spectrometry, it has become possible to evaluate whole visible and innon-visiable absorptive spectrum in human specimens, which may enable detection of minor changes in compound related with altered metabolome and microbiota. We hope to utilize hyperspectral imagingthis spectrum technology to reveal the possible clues of neoplasm for early stage detection

Material and Methods This research intended to enroll one hundred patients into the study. This includes patients with positive stool or urine analysis admitted for workup of colorectal cancer. We will scan the stool and urine with hyperspectral imaging sensoroptical spectrometer, which utilize multichannel charge-coupled device and InGaAs array to analyze the full spectrum of light patterns. The image pattern will be stored and used to linked final diagnosis. Absorption, scattering, and reflection spectra are expected for analysis. Follow up analysis after cancer staging will be used for lowering background noise in all spectra.

Expected Results We expect that there will be specific spectral pattern in stool of colorectal cancer patients, which may be related with cancer staging and different from those in patients without malignancy. Difference in spectra will lead to discovery of new biomarker for colorectal cancer and related diseases. The optic spectra pattern of stool and urine may assist early diagnosis and staging of different malignancies


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 30, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients with positive stool or urine analysis

- above 20 year-old

- previous stool or urine analysis negative 8 weeks ago

Exclusion Criteria:

- pregnancy

- active gastrointestinal disease one year ago

- active infection

- having surgery within a year

- underlying active gastrointestinal, urinary tract, and coagulation disease

Study Design


Related Conditions & MeSH terms

  • Hyperspectral Imaging Data of Excreta
  • Neoplasms

Intervention

Diagnostic Test:
hyperspectral imaging
using hyperspectral detector for evaluation excreta pattern

Locations

Country Name City State
Taiwan Dong-Ru Ho Chiayi City

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary neoplasm diagnosis pathology diagnosis in examination 6 months after examination