Hyperspectral Imaging for Neoplasm Early Stage Detection (HINED)

March 24, 2018 updated by: Dong-Ru Ho, Chang Gung Memorial Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 613
        • Recruiting
        • Dong-Ru Ho
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with positive stool or urine analysis who are above 20 year-old

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
neoplasm diagnosis
Time Frame: 6 months after examination
pathology diagnosis in examination
6 months after examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201701068B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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