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The OctavaColon tests are qualitative plasma tests that are indicated to people above 18 years of age suspected with colon abnormality. The blood tests will provide additional information to the doctor in the course of colon cancer diagnosis for both normal population and high risk population
The clinical objective of this study is to develop two antibody-based blood tests for additional information during colon cancer diagnosis -
The study will be considered successful it can achieve at least one of the following sets of performances -
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy_0 | healthy, people with normal (negative) colonoscopy results. | ||
| patient_1 | people with biopsy/surgery verified carcinoma of the colon, either an Adenocarcinoma, or carcinoma in situ | ||
| benign_2 | people with biopsy verified benign polyps of the colon one of the following - Villus adenoma, Tubular adenoma, Low grade dysplasia, Intermediate grade dysplasia, High grade dysplasia, Severe dysplasia |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants in each of the clinicaly defined groups (0,1 and 2). | 3 years |
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Inclusion Criteria:
Subjects 18 years or over. Subjects scheduled for colonoscopy or surgery
Exclusion Criteria:
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There are 3 different populations that will participate in the study-
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galit Yahalom, Ph.D | Contact | +972546922422 | galit@eventusdx.com |
| Name | Affiliation | Role |
|---|---|---|
| Galit Yahalom, Ph.D. | Eventus Dx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Not yet recruiting | Beersheba | 85025 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24324350 | Background | Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Human plasma samples
| "Carmel" Medical Center | Not yet recruiting | Haifa | 34362 | Israel |
|
| Sheba Tel hashomer | Recruiting | Ramat Gan | 52621 | Israel |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |