NCT03619356

Brief Summary

The specific aims of the project are performing a pre-clinical study on a human model and evaluating the oxygenation and other status of human erythrocytes by spectrally-resolved third harmonic generation (srTHG) microscopy . By analyzing the partitioned third harmonic generation (THG) spectra of oxygenated and deoxygenated erythrocytes ex vivo, the investigators aim to provide a reference standard for quantifying oxygenation and molecular status in this project.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 21, 2024

Status Verified

November 1, 2023

Enrollment Period

6.9 years

First QC Date

June 11, 2018

Last Update Submit

August 19, 2024

Conditions

Keywords

hemoglobinoxygenation concentrationtumordiabetes

Outcome Measures

Primary Outcomes (3)

  • Observe the extent of tumor growth via morphological information

    To observe the extent of tumor growth (with units of mm2) via morphological information. Morphological information are presented as density and shape of red blood cells.

    2 years

  • Observe the extent of tumor growth via spectral THG intensity distribution

    To observe the extent of tumor growth (with units of mm2) via spectral THG distributions. The spectral distributions are presented by the ratio between different channels. And the ratio can be calculated by analyzing the excited fluorescence intensity.

    2 years

  • Change in spectral THG strength distribution

    Obtain THG strength in 3 different channels for chemically treated whole blood samples for oxygenation, deoxygenation and other status. The spectral distributions are presented by the ratio between different channels.

    2 years

Secondary Outcomes (1)

  • Quantify the extent of diseases in spectral THG strength distribution

    1 year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Volunteers with any genders with the age older than 20 years.

You may qualify if:

  • older than 20 years old

You may not qualify if:

  • Vulnerable groups, such as pregnant women, prisoners, students, mentally handicapped, aborigines, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

HypoxiaNeoplasmsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

August 7, 2018

Study Start

February 5, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 21, 2024

Record last verified: 2023-11

Locations