Hyperspectral Imaging Data of ExcretaHINEDNCT03483974
Hyperspectral Imaging for Neoplasm Early Stage Detection
An observational study of Hyperspectral Imaging Data of Excreta, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperspectral Imaging Data of Excreta
- What is being tested?
- hyperspectral imaging
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 30 Sep 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with positive stool or urine analysis who are above 20 year-old
Who may be able to join
- patients with positive stool or urine analysis
- above 20 year-old
- previous stool or urine analysis negative 8 weeks ago
Who cannot join
- pregnancy
- active gastrointestinal disease one year ago
- active infection
- having surgery within a year
- underlying active gastrointestinal, urinary tract, and coagulation disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dong-Ru Ho
Chiayi City, 613
DONG-RU HO, +886919861588, redoxdrh@gmail.com
About this study
Official title: Utilize Hyperspectral Imaging to Reveal the Possible Clues of Neoplasm for Early Stage Detection
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
Read the 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
- Conditions
- Hyperspectral Imaging Data of Excreta
- Being tested
- hyperspectral imaging
- Keywords
- Hyperspectrum, excreta, neoplasm,
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperspectral imagingDiagnostic test
using hyperspectral detector for evaluation excreta pattern
| Study group | Role | What they receive |
|---|---|---|
| neoplasm | neoplasm found in follow up Receives: Diagnostic Test: hyperspectral imaging | |
| non-neoplasm | non-neoplasm patients in follow up Receives: Diagnostic Test: hyperspectral imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
neoplasm diagnosis
pathology diagnosis in examination
Measured: 6 months after examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Aug 2017
- Primary completion1 Aug 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperspectral Imaging Data of ExcretaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ru Ho, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483974
- Sponsor's protocol ID
- 201701068B0
- Acronym
- HINED
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilize Hyperspectral Imaging to Reveal the Possible Clues of Neoplasm for Early Stage Detection
- ClinicalTrials.gov ID
- NCT03483974
- Acronym / sponsor ID
- HINED / 201701068B0
- Conditions
- Hyperspectral Imaging Data of Excreta
- Keywords
- Hyperspectrum, excreta, neoplasm,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoplasm | – | Diagnostic Test: hyperspectral imagingneoplasm found in follow up |
| non-neoplasm | – | Diagnostic Test: hyperspectral imagingnon-neoplasm patients in follow up |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with positive stool or urine analysis who are above 20 year-old
Key inclusion criteria (3 listed)
- patients with positive stool or urine analysis
- above 20 year-old
- previous stool or urine analysis negative 8 weeks ago
Key exclusion criteria (5 listed)
- pregnancy
- active gastrointestinal disease one year ago
- active infection
- having surgery within a year
- underlying active gastrointestinal, urinary tract, and coagulation disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperspectral imagingusing hyperspectral detector for evaluation excreta pattern | Diagnostic test | neoplasm, non-neoplasm |
Primary outcome
neoplasm diagnosis
Time frame: 6 months after examination
pathology diagnosis in examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperspectral Imaging Data of Excreta, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Shou Chen (+886975353211, cgmh5093@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neoplasm diagnosis (time frame: 6 months after examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.