Project deliverable Open Access

G-DEFINER CRFs

Miceli, Rosalba

https://gdefiner.net/

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
CRF 01 - Informed consent and screening.pdf
md5:9e76ba9ce7449946208ed3671708681a
300.2 kB Download
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
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
CRF 07 - Study specific blood and stool samples.pdf
md5:03b3365f6c069fd533cfe3aa48dac685
404.5 kB Download
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
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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