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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-03446 | Other Identifier | NCI Trial Identifier | |
| U54CA136465 | U.S. NIH Grant/Contract | View source |
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Change in personnel and cessation of funding
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopy arm | Experimental | imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual axis endoscopic microscope | Device | This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Imaging of the Mucosa | Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia | 5 years |
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Inclusion Criteria:patients be at least 18 years of age,
Either genders
All ethnic backgrounds will be considered.
Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study.
The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.
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| Name | Affiliation | Role |
|---|---|---|
| Shai Friedland | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endoscopy Arm | imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endoscopy Arm | imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Imaging of the Mucosa | Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia | Posted | Count of Participants | Participants | 5 years |
|
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endoscopy Arm | imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shai Friedland, MD | Stanford University | (650) 617-2732 | shaif@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2021 | May 31, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D013274 | Stomach Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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|
| wide field fluorescence system | Device | This is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope. |
|
|
| CellVizio | Device | Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols. |
|
|
| fluorescent Peptide | Drug | microdosing; Topical through the endoscope |
|
|
| fluorescein | Drug | 100 mcg topical |
|
|
| indocyanine green | Drug | 100 mcg topical |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D009369 | Neoplasms |
| D013272 | Stomach Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |