{"id":118881,"date":"2026-04-23T14:36:34","date_gmt":"2026-04-23T14:36:34","guid":{"rendered":"https:\/\/www.proceadecrc03study.com\/?page_id=118881"},"modified":"2026-04-23T18:31:04","modified_gmt":"2026-04-23T18:31:04","slug":"assessments","status":"publish","type":"page","link":"https:\/\/www.proceadecrc03study.com\/soa\/screening\/assessments\/","title":{"rendered":"\u2014 \u2014 Screening Assessments"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;212522&#8243;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;206826&#8243;][vc_button button_color=&#8221;color-166208&#8243; size=&#8221;btn-link&#8221; link=&#8221;url:https%3A%2F%2Fwww.proceadecrc03study.com%2Fsoa%2Fscreening%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;201369&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-166208&#8243; uncode_shortcode_id=&#8221;338094&#8243; text_color_type=&#8221;uncode-palette&#8221;]Screening Phase[\/vc_custom_heading][vc_column_text text_lead=&#8221;yes&#8221; uncode_shortcode_id=&#8221;322789&#8243;]<span style=\"font-weight: 400;\">Scroll to the screening window timeframe below to see assessment and procedures.<\/span>[\/vc_column_text][vc_empty_space empty_h=&#8221;2&#8243;][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;978008&#8243; back_color_type=&#8221;uncode-solid&#8221; back_color_solid=&#8221;#f1fbff&#8221; row_name=&#8221;1&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-166208&#8243; size=&#8221;btn-link&#8221; link=&#8221;url:https%3A%2F%2Fwww.proceadecrc03study.com%2Fsoa%2Fscreening%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;101999&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-166208&#8243; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;139116&#8243; text_color_type=&#8221;uncode-palette&#8221;]Within 28 days before C1D1[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;205426&#8243; title=&#8221;Informed consent&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;395253&#8243; title=&#8221;Inclusion and exclusion criteria&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;183648&#8243; title=&#8221;Demography&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;593653&#8243; title=&#8221;Past and current medical history&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;570782&#8243; title=&#8221;Disease history&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;195568&#8243; title=&#8221;Prior anticancer therapies&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;166390&#8243; title=&#8221;Archival tumor tissue collection&#8221;]If archival tumor tissue is not available, fresh biopsy sample is required. See Protocol Section 8.6 for further details.[\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;234623&#8243; title=&#8221;HIV, hepatitis B, and C screening&#8221;]HIV: at the Investigator\u2019s discretion unless locally required.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;243657&#8243; title=&#8221;Iron deficiency testing (ferritin, TSAT)&#8221;]See Protocol Section 8.2.4 and Appendix 5.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;255226&#8243; title=&#8221;12-lead ECG&#8221;]See Protocol Section 8.2.3.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;789991&#8243; title=&#8221;Serum biomarker sample&#8221;]Once during Screening. See Protocol Section 8.6. See Protocol Appendix 7 for China-specific guidance.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;149057&#8243; title=&#8221;AE and SAE review&#8221;]From the time of signing ICF to Safety Follow-up Visit.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;139572&#8243; title=&#8221;Concomitant medication and procedures review&#8221;]From the time of signing ICF to Safety Follow-up Visit.[\/vc_icon][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;198735&#8243; row_name=&#8221;2&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-166208&#8243; size=&#8221;btn-link&#8221; link=&#8221;url:https%3A%2F%2Fwww.proceadecrc03study.com%2Fsoa%2Fscreening%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;184645&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-166208&#8243; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;204728&#8243; text_color_type=&#8221;uncode-palette&#8221;]Within 14 days before C1D1[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;487976&#8243; title=&#8221;CT Scan \/ MRI&#8221;]See Protocol Section 8.1.1.[\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;164075&#8243; row_name=&#8221;3&#8243; back_color_type=&#8221;uncode-solid&#8221; back_color_solid=&#8221;#f1fbff&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-166208&#8243; size=&#8221;btn-link&#8221; link=&#8221;url:https%3A%2F%2Fwww.proceadecrc03study.com%2Fsoa%2Fscreening%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;134744&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-166208&#8243; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;826519&#8243; text_color_type=&#8221;uncode-palette&#8221;]Within 7 days before C1D1[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;519883&#8243; title=&#8221;Physical examination&#8221;][\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;553494&#8243; title=&#8221;Pregnancy test (POCBP only)&#8221;]Serum only at Screening.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;383718&#8243; title=&#8221;Hematology and biochemistry&#8221;]See Protocol Section 8.2.4 and Appendix 5.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;207054&#8243; title=&#8221;Coagulation&#8221;]See Protocol Section 8.2.4 and Appendix 5.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;752785&#8243; title=&#8221;CRP&#8221;]See Protocol Section 8.2.4 and Appendix 5.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;626018&#8243; title=&#8221;Routine urinalysis&#8221;]Urinalysis per dipstick testing. Microscopic examination if blood or protein abnormality. Protein analysis if dipstick 2+ (see Protocol Section 8.2.4 and Appendix 5).[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;124036&#8243; title=&#8221;ECOG performance status&#8221;][\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;947898&#8243; title=&#8221;Vital signs&#8221;]Height, weight, BMI, blood pressure, pulse, respiratory rate, and temperature. See Protocol Section 8.2.2.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;174332&#8243; title=&#8221;EQ-5D-5L&#8221;]See Protocol Section 8.1.2.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;188798&#8243; title=&#8221;EORTC QLQ-C30&#8243;]See Protocol Section 8.1.2.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;128448&#8243; title=&#8221;Custom EORTC form (5 questions)&#8221;]See Protocol Section 8.1.2.[\/vc_icon][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;2&#8243; top_padding=&#8221;7&#8243; bottom_padding=&#8221;7&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;3&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; content_parallax=&#8221;0&#8243; uncode_shortcode_id=&#8221;103069&#8243; row_name=&#8221;4&#8243;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;3&#8243; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_width=&#8221;0&#8243; mobile_width=&#8221;0&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;210430&#8243;][vc_button button_color=&#8221;color-166208&#8243; size=&#8221;btn-link&#8221; link=&#8221;url:https%3A%2F%2Fwww.proceadecrc03study.com%2Fsoa%2Fscreening%2F|title:SOA&#8221; button_color_type=&#8221;uncode-palette&#8221; icon=&#8221;fa fa-arrow-left2&#8243; uncode_shortcode_id=&#8221;173996&#8243;]Back[\/vc_button][vc_custom_heading text_color=&#8221;color-166208&#8243; heading_semantic=&#8221;h3&#8243; text_size=&#8221;h3&#8243; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;797693&#8243; text_color_type=&#8221;uncode-palette&#8221;]Within 3 days before or on C1D1[\/vc_custom_heading][vc_empty_space empty_h=&#8221;2&#8243;][vc_row_inner row_inner_height_percent=&#8221;0&#8243; overlay_alpha=&#8221;50&#8243; gutter_size=&#8221;4&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; uncode_shortcode_id=&#8221;499424&#8243;][vc_column_inner width=&#8221;1\/2&#8243;][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;385531&#8243; title=&#8221;Inclusion and exclusion criteria&#8221;]Recheck before randomization.[\/vc_icon][vc_icon position=&#8221;left&#8221; icon=&#8221;fa fa-check&#8221; heading_semantic=&#8221;h6&#8243; text_size=&#8221;h6&#8243; uncode_shortcode_id=&#8221;172707&#8243; title=&#8221;Randomization&#8221;][\/vc_icon][\/vc_column_inner][vc_column_inner width=&#8221;1\/2&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row row_height_percent=&#8221;0&#8243; 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