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| Data Fields | Sample TSR Data | Sample Corresponding XML Data | Comments |
|---|---|---|---|
| Record Verification Date | 2013-03 | <verification_date>2013-03</verification_date> | NA |
Trial Category | Complete | (Not included in the XML file) | ClinicalTrials.gov does not capture this field |
Trial Type | Interventional | <study_type>Interventional</study_type> | NA |
NCI Trial Identifier | NCI-2011-9999 | <id_info> <secondary_id> <id>NCI-2011-99999</id> <id_type>Registry Identifier</id_type> <id_domain>CTRP (Clinical Trial Reporting Program)</id_domain> </secondary_id></id_info> | NA |
ClinicalTrials.gov Identifier | NCT01234567 | (Not included in the XML file) | NA |
Lead Organization (Trial) Identifier | CCCCWFU 12345 | <org_study_id>CCCCWFU 12345</org_study_id>and
| Wake Forest University Health Sciences is the Lead Organization in this example |
DCP Identifier | WFU-01-01-06 | <id_info> <secondary_id> <id>WFU-01-01-06</id> <id_type>Registry Identifier</id_type> <id_domain>DCP</id_domain> </secondary_id></id_info> | ClinicalTrials.gov captures all other identifiers as <secondary_id> |
CTEP Identifier | WFU-01-01-06 | <id_info> <secondary_id> <id>WFU-01-01-06</id> <id_type>Registry Identifier</id_type> <id_domain>CTEP</id_domain> </secondary_id></id_info> | ClinicalTrials.gov captures all other identifiers as <secondary_id> |
CCR Identifier | CCR-123 | (Not included in the XML file) | ClinicalTrials.gov captures all other identifiers as <secondary_id> |
| Amendment Date | 02/10/2003 | (Not included in the XML file) | ClinicalTrials.gov does not capture this field |
| Amendment Number | 35 | (Not included in the XML file) | ClinicalTrials.gov does not capture this field |
Type | Interventional | <study_type>Interventional</study_type> | NA |
Official Title | A Phase II Double-Blind Feasibility Study of Armodafinil... | <official_title> A Phase II Double-Blind Feasibility Study of Armodafinil...</official_title> | NA |
Brief Title | Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors | <brief_title> Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors</brief_title> | NA |
| Acronym | ABC | <acronym> | NA |
| Brief Summary | This clinical trial is studying how well Armodafinil works... | <brief_summary> <textblock> This clinical trial is studying how well Armodafinil works... <textblock><brief_summary> | NA |
| Detailed Description | Detailed Description... | <detailed_description> <textblock> Detailed Description... </textblock></detailed_description> | NA |
| Primary Objectives | I. To estimate... | <detailed_description> <textblock> PRIMARY OBJECTIVES: I. To estimate... </textblock></detailed_description> | NA |
| Secondary Objectives | I. To obtain a preliminary estimate... | <detailed_description> <textblock> SECONDARY OBJECTIVES: To obtain a preliminary estimate... </textblock></detailed_description> | NA |
| Outline | OUTLINE: This is a multicenter study... | <detailed_description> <textblock> OUTLINE: This is a multicenter study... </textblock></detailed_description> | NA |
Keywords | Feasibility Armodafinil; narcolepsy | <keyword>Feasibility Armodafinil</keyword><keyword>narcolepsy</keyword> | NA |
Reporting Dataset Method | Complete | (Not included in the XML file) | Not required for the ClinicalTrials.gov schema |
Sponsor | National Cancer Institute | <sponsors> <lead_sponsor> <agency>National Cancer Institute</agency> </lead_sponsor></sponsors> | NA |
Lead Organization | Wake Forest University Health Sciences | | NA |
Principal Investigator | Jane Doe | <overall_official> <first_name>Jane</first_name> <last_name>Doe</last_name> <role>Principal Investigator</role> <affiliation>Wake Forest University Health Sciences</affiliation></overall_official> | NA |
Responsible Party | Sponsor | <resp_party_type>Sponsor</resp_party_type> | NA |
Overall Official | Jane Doe (Principal Investigator) Wake Forest University Health Sciences | | NA |
Current Trial Status | Closed to Accrual and Intervention as of 08/01/2012 | <overall_status>Active, not recruiting</overall_status> | NA |
Trial Start Date | 08/01/2010-Actual | <start_date>2010-08</start_date><start_date_type>Actual</start_date_type> | NA |
Primary Completion Date | 01/11/2014-Actual | <primary_compl_date>2014-01</primary_compl_date><primary_compl_date_type>Actual</primary_compl_date_type> | NA |
Completion Date | 02/04/2014-Actual |
If no data are available, the "<last_follow_up_date>" does not appear in the XML file. | Not required for the ClinicalTrials.gov schema |
| Regulatory Information > Studies a U.S. FDA-regulated Drug Product | Yes | <oversight_info> <fda_regulated_drug>Yes</fda_regulated_drug></oversight_info> | NA |
| Regulatory Information > Studies a U.S. FDA-regulated Device Product | Yes | <oversight_info> <fda_regulated_device>Yes</fda_regulated_device></oversight_info> | NA |
| Regulatory Information > Unapproved/Uncleared Device? | Yes | <delayed_posting>Yes</delayed_posting> | NA |
| Regulatory Information > Post Prior to U.S. FDA Approval or Clearance | Yes | <oversight_info> <post_prior_to_approval>Yes</post_prior_to_approval></oversight_info> | NA |
| Regulatory Information > Pediatric Post-market Surveillance (of a Device Product) | Yes | <oversight_info> <ped_postmarket_surv>Yes</ped_postmarket_surv></oversight_info> | NA |
| Regulatory Information > Product Exported from the U.S. | Yes | <oversight_info> <exported_from_us>Yes</exported_from_us></oversight_info> | NA |
Regulatory Information > FDA Regulated Intervention? | Yes | <is_fda_regulated>Yes</is_fda_regulated> | NA |
Regulatory Information > Section 801? | Yes | <is_section_801>Yes</is_section_801> | NA |
Regulatory Information > DMC Appointed? | Yes | <oversight_info> <has_dmc>Yes</has_dmc></oversight_info> | NA |
Regulatory Information > IND/IDE Study? | Yes | <is_ind_study>Yes</is_ind_study> | NA |
Board Approval Status | Submitted, approved | <irb_info> <approval_status>Approved</approval_status></irb_info> | NA |
Board Approval Number | IRB00012856 | <irb_info> <approval_number>IRB00012856</approval_number></irb_info> | NA |
Board | Wake Forest University Health Sciences | <irb_info> <name>Wake Forest University Health Sciences</name></irb_info> | NA |
Affiliation | Wake Forest University Health Sciences | <irb_info> <affiliation>Wake Forest University Health Sciences</affiliation></irb_info> | NA |
| IND/IDE > Type | IND | <ind_info> | Applies to IND and IDE |
| IND/IDE > Grantor | CBER | <ind_grantor>CBER</ind_grantor> | NA |
| IND/IDE > Number | 119999 | <ind_number>119999</ind_number> | NA |
| IND/IDE > Holder Type | NCI | (Not included in the XML file) | NA |
| IND/IDE > Availability of Expanded Access | Yes | <has_expanded_access>Yes</has_expanded_access> | NA |
| IND/IDE > Expanded Access Record | NCT12345678 | <expanded_access_nct_id>NCT12345678</expanded_access_nct_id> | NA |
NIH Grants > Funding Mechanism | U10 | <secondary_id> <id>U10CA88888</id> <id_type>NIH Grant Number</id_type></secondary_id> | NA |
NIH Grants > NIH Institution Code | CA | <secondary_id> <id>U10CA88888</id> <id_type>NIH Grant Number</id_type></secondary_id> | NA |
| NIH Grants > Serial Number | 88888 | <secondary_id> <id>U10CA88888</id> <id_type>NIH Grant Number</id_type></secondary_id> | NA |
| NIH Grants > NCI Division/Program Code | DCP | (Not included in the XML file) | NA |
Data Table 4 Information > Funding Category | Externally Peer-Reviewed | (Not included in the XML file) | Not required for the ClinicalTrials.gov schema |
Data Table 4 Information > Funding Sponsor/Source | National Cancer Institute | (Not included in the XML file) | Not required for the ClinicalTrials.gov schema |
| Data Table 4 Information > Program Codes | 2, 5, 12 | (Not included in the XML file) | NA |
| Anatomic Site Code | Prostate | (Not included in the XML file) | Not required for the ClinicalTrials.gov schema |
| Collaborator Name | National Cancer Institute | <collaborator> <agency>National Cancer Institute</agency></collaborator> | Not required for the ClinicalTrials.gov schema |
| Collaborator Role | Funding Source | (Not included in the XML file) | ClinicalTrials.gov does not capture this field |
| Disease/Condition Name | Prostate Carcinoma | <condition>Prostate Carcinoma</condition> | NA |
Trial Design > Type | Interventional |
| NA |
| Trial Design > Expanded Access | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Trial Design > Primary Purpose | Prevention | <study_design> <interventional_design> <interventional_subtype>Prevention</interventional_subtype> </interventional_design></study_design> | NA |
Pragmatic Trial | Yes | (Not included in the XML file) | NA |
Trial Design > Phase | II | <study_design> <interventional_design> <phase>II</phase> </interventional_design></study_design> | NA |
Trial Design > Interventional Study Model | Parallel | <study_design> <interventional_design> <assignment>Parallel Assignment</assignment> </interventional_design></study_design> | NA |
Trial Design > Model Description | Lorem ipsum dolor sit amet ... | <study_design> <interventional_design> <model_description> <textblock>Lorem ipsum dolor sit amet ... </textblock> </model_description> </interventional_design></study_design> | NA |
Trial Design > Number of Arms | 2 | <study_design> <interventional_design> <number_of_arms>2</number_of_arms> </interventional_design></study_design> | NA |
Trial Design > Masking | Participant, Investigator, Care Provider, Outcomes Assessor | <study_design> <interventional_design> <no_masking>No</no_masking> <masked_assessor>Yes</masked_assessor> <masked_caregiver>Yes</masked_caregiver> <masked_investigator>Yes</masked_investigator> <masked_subject>Yes</masked_subject> </interventional_design></study_design> | NA |
Trial Design > Masking Description | Lorem ipsum dolor sit amet ... | <study_design> <interventional_design> <masking_description> <textblock>Lorem ipsum dolor sit amet ... </textblock> </masking_description> </interventional_design></study_design> | NA |
Trial Design > Allocation | Randomized Controlled Trial | <study_design> <interventional_design> <allocation>Randomized Controlled Trial</allocation> </interventional_design></study_design> | NA |
Trial Design > Target Enrollment | 100 | <enrollment>100</enrollment> | NA |
Eligibility Criteria > Accepts Healthy Volunteers? | No | <eligibility> <healthy_volunteers>No</healthy_volunteers></eligibility> | NA |
Eligibility Criteria > Sex | Female | <eligibility> <gender>Female</gender></eligibility> | NA |
Eligibility Criteria > Gender Based | Yes | <eligibility> <gender_based>Yes</gender_based></eligibility> | NA |
Eligibility Criteria > Gender Eligibility Description | Lorem ipsum dolor sit amet ... | <eligibility> <gender_description> <textblock>Lorem ipsum dolor sit amet ... </textblock> </gender_description></eligibility> | NA |
Eligibility Criteria > Minimum Age | 18 Years | <eligibility> <minimum_age>18 years</minimum_age></eligibility> | NA |
Eligibility Criteria > Maximum Age | N/A | <eligibility> <maximum_age>N/A</maximum_age></eligibility> | NA |
Eligibility Criteria > Inclusion Criteria | Family history of prostate cancer... | <eligibility> <criteria> <textblock>Inclusion Criteria: Family history of prostate cancer...</textblock> </criteria></eligibility> | NA |
| Eligibility Criteria > Exclusion Criteria | Patient must not have had radiation therapy in the pelvic area... | <eligibility> <criteria> <textblock>Exclusion Criteria: Patient must not have had radiation therapy in the pelvic area...</textblock> </criteria></eligibility> | NA |
| Intervention(s) > Type | Drug | <intervention_type>Drug</intervention_type> | NA |
| Intervention(s) > Name | Armodafinil | <intervention_name>Armodafinil</intervention_name> | NA |
| Intervention(s) > Alternate Name | 2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,... | <intervention_other_name> 2-(difluoromethyl)-DL-ornithine, 2-(difluoromethyl)-dl-ornithine Hydrochloride,...</intervention_other_name> | NA |
| Intervention(s) > Description | Given orally | <intervention_description> <textblock>Given orally</textblock></intervention_description> | NA |
| Arm/Group(s) > Type | Placebo Comparator | <arm_type>Placebo Comparator</arm_type> | NA |
| Arm/Group(s) > Label | Arm II | <arm_group_label>Arm II</arm_group_label> | NA |
| Arm/Group(s) > Description | Patients receive oral Armodafinil once daily... | <arm_group_description> <textblock>Patients receive oral Armodafinil once daily...</textblock></arm_group_description> | NA |
| Primary Outcome Measures > Title | Accrual rate estimated as the number of patients ... | <primary_outcome> <outcome_measure>Accrual rate estimated as the number of patients ...</outcome_measure></primary_outcome> | NA |
| Primary Outcome Measures > Description | Estimated using an analysis of covariance (ANCOVA) model which includes... | <outcome_description> <textblock>Estimated using an analysis of covariance (ANCOVA) model which includes...</textblock></outcome_description> | NA |
| Primary Outcome Measures > Time Frame | Up to 2 years | <outcome_time_frame>Up to 2 years</outcome_time_frame> | NA |
| Secondary Outcome Measures > Title | Incidence of toxicity incidents... | <secondary_outcome> <outcome_measure>Incidence of toxicity incidents assessed...</outcome_measure><secondary_outcome> | NA |
| Secondary Outcome Measures > Description | NA | <outcome_description> | NA |
| Secondary Outcome Measures > Time Frame | Up to 2 years | <outcome_time_frame>Up to 2 years</outcome_time_frame> | NA |
Sub-groups Stratification Criteria > Label | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Sub-groups Stratification Criteria > Description | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Marker Name | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Evaluation Type | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Assay Type | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Biomarker Use | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Biomarker Purpose | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
Markers > Specimen Type | (Not included in the TSR) | (Not included in the XML file) | Data field in Protocol Abstraction |
| Participating Sites > Facility | Wake Forest University Health Sciences Winston-Salem, NC 27106 United States | <location> <facility> <name>Wake Forest University Health Sciences</name> <address> <city>Winston-Salem</city> <state>NC</state> <zip>27106</zip> <country>United States</country> </address> </facility></location> | NA |
| Participating Sites > Contact | Doe, Jane, M. phone:123-123-1234 Email:jmd@domain.com | <location> <contact> <first_name>Jane</first_name> <middle_name>M</middle_name> <last_name>Doe</last_name> <phone>123-123-1234</phone> <email>jmd@domain.com</email> </contact></location> | NA |
| Participating Sites > Recruitment Status and Dates | Enrolling by Invitation as of 05/09/2014 | <location> <status>Enrolling by Invitation</status></location> | NA |
| Participating Sites > Target Accrual | 40 | (Not included in the XML file) | ClinicalTrials.gov does not capture this field |
| Participating Sites > Investigators | Doe, Jane, Principal Investigator | <investigator> <first_name>Jane</first_name><last_name>Doe</last_name><role>Principal Investigator</role></investigator> | NA |
