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The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organoid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Other | Tissue biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsies That Form Spherical Organoids | Baseline |
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Inclusion
Exclusion
1. Patient not planned to receive neoadjuvant radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Brian Czito, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Durham | North Carolina | 27710 | United States |
Data and organoids may be shared with other researchers
6 months after publication
Researchers should request data and/or organoid lines from the principal investigator
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| ID | Title | Description |
|---|---|---|
| FG000 | Organoid | Biopsy: Tissue biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Organoid | Biopsy: Tissue biopsy |
| 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 Biopsies That Form Spherical Organoids | Participants with sufficient sample collected. | Posted | Count of Participants | Participants | Baseline |
|
|
Adverse Event data was not collected.
Adverse Event data was not collected.
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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 | Organoid | Biopsy: Tissue biopsy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Cahill BNS OCN CCRP | Duke University Health System | (919) 668-5211 | Joan.Cahill@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Oct 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |