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 <id_info>
<secondary_id>
<id>CCCCWFU 12345</id>
<id_type>Other Identifier</id_type>
<id_domain>Wake Forest University Health Sciences</id_domain>
</secondary_id>
</id_info>
| 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 | <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 |
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 | <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 |
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 | <last_follow_up_date>2014-02</last_follow_up_date>
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 | <study_type>Interventional</study_type> and
<study_design>Interventional</study_design>
| 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 |