Project deliverable Open Access
G-DEFINER CRFs
Miceli, Rosalba
Project: "Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment"
(G-DEFINER).
Clinical study CRFs. (DOI of the Study Protocol: 10.5281/zenodo.4142124)
This is a multicenter observational prospective clinical study aimed at investigating the inequalities between female (F) and male (M) patients in the development of immune-related adverse events (irAEs) associated with immunotherapy treatment. The evaluation of the differences in terms of irAEs incidence concerning biological aspects will be integrated by the exploration of their gender dimension.
Files
(3.6 MB)
| Name | Size | |
|---|---|---|
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CRF 01 - Informed consent and screening.pdf
md5:9e76ba9ce7449946208ed3671708681a |
300.2 kB | Download |
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CRF 02 - Registration and baseline.pdf
md5:7b8e59a29dddc2557b2feb0f4d4ccf34 |
437.0 kB | Download |
|
CRF 03 - Immune-Related Adverse Event Log.pdf
md5:8cf9aff5eb0f7a9c73c7e5e1a7bcd69e |
418.3 kB | Download |
|
CRF 04 - Lab tests and concomitant medications.pdf
md5:56ce54905fd27cc86f41c3ccb1abc962 |
351.1 kB | Download |
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CRF 05 - Questionnaires distress and health.pdf
md5:7f636af6fb4cb5fe0b47abffc9e73df8 |
420.7 kB | Download |
|
CRF 06 - Follow up log.pdf
md5:8426e929b3fe4c2431c771205358296b |
275.3 kB | Download |
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CRF 07 - Study specific blood and stool samples.pdf
md5:03b3365f6c069fd533cfe3aa48dac685 |
404.5 kB | Download |
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CRF 08 - Off study.pdf
md5:21572912f11bf38100820705013031f7 |
249.7 kB | Download |
|
CRF 09 - ICI and oncologic treatments log.pdf
md5:c4b78ec52bf59623a905668fd7123aeb |
218.7 kB | Download |
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CRF 10 - Diet form.pdf
md5:ef437dbafe94e3c92f0887dc8fdbd23c |
276.3 kB | Download |
|
CRF 11 - Pre-Screening form.pdf
md5:a703c29a00c1ef6bb162c70d95f8998d |
223.3 kB | Download |
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108
views
downloads
| All versions | This version | |
|---|---|---|
| Views | 99 | 99 |
| Downloads | 108 | 108 |
| Data volume | 34.0 MB | 34.0 MB |
| Unique views | 76 | 76 |
| Unique downloads | 86 | 86 |
Indexed in
- Publication date:
- October 27, 2020
- DOI:
-
- Keyword(s):
- Clinical Oncology, Immunotherapy, Sex, Gender, Biology, Biostatistics. Bioinformatics
- Grants:
-
European Commission:
- GENDER NET Plus - ERA-NET Cofund Promoting Gender Equality in H2020 and the ERA (741874)
- License (for files):
- Creative Commons Attribution 4.0 International