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Hyperspectral Imaging for Neoplasm Early Stage Detection (HINED)

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ClinicalTrials.gov Identifier: NCT03483974
Recruitment Status : Unknown
Verified March 2018 by Dong-Ru Ho, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-Ru Ho, Chang Gung Memorial Hospital

Brief 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


Condition or disease Intervention/treatment
Hyperspectral Imaging Data of Excreta Diagnostic Test: hyperspectral imaging

Detailed 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Utilize Hyperspectral Imaging to Reveal the Possible Clues of Neoplasm for Early Stage Detection
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
neoplasm
neoplasm found in follow up
Diagnostic Test: hyperspectral imaging
using hyperspectral detector for evaluation excreta pattern

non-neoplasm
non-neoplasm patients in follow up
Diagnostic Test: hyperspectral imaging
using hyperspectral detector for evaluation excreta pattern




Primary Outcome Measures :
  1. neoplasm diagnosis [ Time Frame: 6 months after examination ]
    pathology diagnosis in examination



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with positive stool or urine analysis who are above 20 year-old
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483974


Contacts
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Contact: Chih-Shou Chen +886975353211 cgmh5093@gmail.com
Contact: DONG-RU HO +14158573127 redoxdrh@gmail.com

Locations
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Taiwan
Dong-Ru Ho Recruiting
Chiayi City, Taiwan, 613
Contact: DONG-RU HO    +886919861588    redoxdrh@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

Additional Information:

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Responsible Party: Dong-Ru Ho, Assistant Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03483974    
Other Study ID Numbers: 201701068B0
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Ru Ho, Chang Gung Memorial Hospital:
Hyperspectrum, excreta, neoplasm,
Additional relevant MeSH terms:
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Neoplasms