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Evaluation of safety of Allogeneic Colon Cancer Cell Vaccinets

ABSTRACT: Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. The allogene vaccine (including three colon cancer cell lines) will be injected in two periods. The first period consists of three consecutive doses: the first dose will be injected one week after diagnosis /surgery, the following two doses will be injected with a week interval. One week after the third injection, chemotherapy will begin. After the first period, chemotherapy begins and continues for six months. The second period of the vaccine starts one month after chemotherapy and includes three consecutive vaccine doses with a distance of one week. Chemotherapy begins and continues two weeks after the sixth injection. 300 million tumor cells (108 cells from each cancer cell line) with 1 million BCG organisms are injected intradermally in the first and second injections. The third, fourth, fifth, and sixth injections contain 300 million irradiated tumor cells. Intervention 2: Control group: Patients with colorectal cancer, stage 4 which receive Chemotherapy treatment 5 weeks after diagnosis /surgery. Primary outcome(s): Measuring the levels of CA19-9. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of CEA. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alanine aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of aspartate aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alkaline phosphatase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of glutamyl tarnspeptidase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Investigation of tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: via colonoscopy. Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.

DISEASE(S): Malignant Neoplasm Of Colon, Malignant Neoplasm Of Rectosigmoid Junction, Malignant Neoplasm Of Rectum, Malignant Neoplasm Of Anus And Anal Canal,C18, C19,Colorectal Cancer, Stage 4

PROVIDER: 2504200 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group. Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.

Project description:Intervention 1: Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test. Intervention 2: Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film. Intervention 3: Intervention group3: free access to fecal occult blood test. Intervention 4: Control group: For the control group will not perform any of the action that will be taken for the intervention group.;Prevention;Prevention;Prevention;Prevention;Intervention group1: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet, film and free access to fecal occult blood test;Intervention group2: Interventions included holding educational sessions, distribution of educational aids tools such as pamphlet and film;Intervention group3: free access to fecal occult blood test;Control group: For the control group will not perform any of the action that will be taken for the intervention group. Primary outcome(s): Perceived severity. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Knowledge. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived susceptibility. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Intention. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived barriers. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Social support. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Self efficacy. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire.;Perceived benefits. Timepoint: Before and 4 months after intervention. Method of measurement: Questionnaire. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening.

Project description:Intervention 1: One group in the study will receive educational intervention. Educational content provided to the intervention group includes an app that is designed based on preventive health model, and an educational pamphlet about colorectal cancer, the importance of screening and a variety of colorectal cancer screening methods. Intervention 2: Control group: One group as a control group will enter the study, that will not receive any training and intervention. Primary outcome(s): Perceived self-efficacy. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Perceived sensitivity. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Worries and fears. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Screening Effectiveness. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Social support. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire.;Behavioral intention. Timepoint: 2 months after the beginning of the study. Method of measurement: Colorectal screening questionnaire. Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Screening, Randomization description: Samples were randomly selected from 2 centers by block sampling method and samples of both groups will be matched based on demographic variables such as age, education, and so on. Random assignment of selected individuals will be done by block random method using quad blocks. For two groups of intervention and comparison use two letters A and B. So the size of each block is twice the number of groups, that is, the number 4. By dividing the sample size by block size, the number of blocks is determined. Sample size is 160 people. Each group consists of 80 people, and the number of blocks in each group is 20 blocks, each of which specifies the assignment of 4 individuals. Finally, all letters A and B are separated, and each person who is not the researcher, by lot, will be suspended by each letter in a group. For example, A intervention group

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Evaluation of safety of Allogeneic Colon Cancer Cell Vaccinets

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