This section will help you understand the information that is shown for each trial. Trial descriptions differ based on the source of the trial. Some trials are directly submitted to PDQ and others are imported from the National Library of Medicine's ClincalTrials.gov database. Details about trial descriptions are given below.

Description for Trials Submitted to PDQ

Title - The title of the trial gives key information about the trial. If you choose to view content for patients, the language of the title will be less technical.

Alternate Title - The alternate title is available for some trials. If you are viewing content for patients, the alternate title will be in more technical language. If you are viewing content for health professionals, the alternate title will be in less technical language.

Basic information about the trial is listed below the title. In some formats, it appears in a summary box.

Basic information box in a trial description.

Phase - Gives information about how far along the drug/treatment/or procedure is in the testing process. The higher the Phase number, the more testing has been done. For definitions of each phase, see the section, How to Find Clinical Trials Using the Search Form.

Type - Describes the overall purpose(s) of the trial. Sometimes multiple Trial Types are listed. See definitions of trial types, in the section How to Find Clinical Trials Using the Search Form.

Status - Shows the current status of the trial. If you searched for Active trials (the default search), you will see one of the following statuses:

• Active - The trial is currently accepting new patients.
• Approved, not yet active - The trial is not yet accepting new patients. It has received scientific approval, but may be waiting for some administrative steps to be complete.

If you selected "Closed" in the status field of the search form, you will see one of the following values:

• Closed - The trial is not accepting new patients. Patients already on the trial may continue to be treated and/or followed.
• Completed - All aspects of the trial are complete. Patients are no longer being followed for data collection.
• Temporarily Closed - The trial is not accepting patients temporarily. Reasons for this may be short supply of the drug, safety issues with the trial, or administrative issues.

Age - Shows the age range of eligible participants for the trial.

Sponsor - Shows who is sponsoring the trial. The National Cancer Institute or other NIH Institutes are identified by name. The other values in this column can be "Pharmaceutical/Industry" or "Other."

Protocol ID - Shows one or more identification number(s) for the trial. One of the numbers displayed in this box may be preceded by the letters "NCT." This is the National Clinical Trial identifier provided by the National Library of Medicine's ClinicalTrials.gov database.

Patient Version of Trial Description

If you choose to view the information written for patients, the display includes the following :

Trial Description - Each trial description contains the following sections:

• Purpose - The type of trial being conducted, what treatments will be given or tests will be performed, and what researchers hope to accomplish.
• Eligibility - The requirements that a person must meet to participate in the trial. These requirements help researchers ensure the safety of participants and the scientific validity of the trial. For example, treatment trials may list type and stage of cancer, age, previous treatment, other health conditions, and more. The patient version of the trial description lists only some of the eligibility criteria. You can use the link to the health professional version of the trial description to see a more complete list.
• Treatment/ Intervention - The type of treatment or intervention, and how often it will be given. For non-treatment trials, a description of what happens on the trial is provided.
• Trial Lead Organizations - A list of one or more academic hospitals, research institutions, pharmaceutical companies, cancer centers, or cooperative groups responsible for coordinating the trial.
• Trial Sites and Contacts - The people or organizations conducting the trial. You or your health care provider can use the contact information to find out more about the trial, including eligibility, the enrollment process, and other details. Site information is not displayed for closed trials.

Health Professional Version of Trial Description

This version provides information about the goals of the trial, the entry criteria for the trial, and what happens on the trial. You or your health care provider can use the contact information to find out more about the trial. Each trial description contains the following sections:

• Objectives- A detailed description of the trial's goals.
• Entry Criteria- A list of the requirements a person must meet to participate in the trial. These are organized in three categories:
• Disease Characteristics - type and stage of cancer or type of disease.
• Prior/Concurrent Therapy - treatments that the participant may have had earlier, for example, whether he or she has already had chemotherapy.
• Patient Characteristics - age, other medical conditions, etc.

See definition of eligibility criteria

• Expected Enrollment -The number of participants expected to be included in the trial.
• Outcomes - The measures that will be used to find out if the trial meets the goals. The measures can be categorized as Primary or Secondary.
• Outline - A description of what will happen to the participant while on the trial. For a treatment trial, it is a description of the treatment plan including the "arms" or groups that participants may be assigned to on the trial.
• Published Results - Reference citations to published scientific reports and papers reporting results of the trial. A link may also be included to the abstract of the publication in the National Library of Medicine's PUBMED database. These are often available for Closed trials.
• Related Publications - Reference citations to published scientific reports and papers that contain information related to the trial. Sometimes results of a trial may be used in a publication that summarizes results from various trials or a review of a particular approach to treatment.
• Related Protocols - Links to trials associated with this trial.
• Related Web sites - Links to Web pages that provide more information about the trial.  For example, some trials at NCI's Center for Cancer Research in Bethesda may link to a trial Web site.
• Trial Contact Information - Information about contacts that you can call or e-mail about the trial. You or your health care provider may want to look for contacts that are close to your location.
• Trial Lead Organizations - A list of one or more academic hospitals, research institutions, pharmaceutical companies, cancer centers, or cooperative groups responsible for coordinating the trial.
• Trial Sites - The people or organizations conducting the trial. They can provide more information about the trial, including eligibility and the enrollment process.

Registry Information - Details related to the laws and requirements for specific types of clinical trials to be registered in the National Library of Medicine's ClinicalTrials.gov database. It also includes a link to the record in the ClinicalTrials.gov database.

Description for Trials Imported from ClinicalTrials.gov

Summary - An outline of the purpose of the study and a general description of what is being done.

Further Study Information - More details about the study, for example, specific information about the treatment plan.

Eligibility Criteria - A list of the requirements a person must meet to participate in the trial. The criteria may be labeled "Inclusion" or "Exclusion". See definition of eligibility criteria.

Trial Contact Information - Information about contacts that you can call or e-mail about this trial. You or your health care provider may want to look for contacts that are close to your location.

• Trial Lead Organizations - A list of one or more academic hospitals, research institutions, pharmaceutical companies, cancer centers, or cooperative groups responsible for coordinating the trial.
• Trial Sites - The people or organizations conducting the trial. They can provide more information about the trial, including eligibility and the enrollment process.  Sometimes there may be a central number for all sites and the name of the hospital/institution may not be provided.

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