Morehouse Total Cancer Care Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of blood, tissue, and other biological samples., Medical Chart Review.
- Who it may be relevant to
- Registry conditions: Cancer, Cancer Risk. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Morehouse Total Cancer Care Protocol: A Lifetime Partnership With Patients Who Have or May be at Risk of Having Cancer
Overview
The overall objective of the Morehouse Total Cancer Care study is to develop an improved standard of cancer care by facilitating new biomarker and drug target discovery, informatics solutions, clinical trials, and "personalized medicine" for our community oncology partners (i.e., community hospital systems, and other cancer care providers). To bring new translational research to the community, Morehouse School of Medicine has initiated the Total Cancer Care Program (TCCP). The TCCP establishes a unique collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from thousands of African American cancer patients, survivors, or those at risk of having cancer. This is not a treatment trial, but a longitudinal study designed to create a centralized cancer biorepository for precision medicine.
Detailed description
Through this protocol, Morehouse School of Medicine and its partners will establish and maintain a unique repository of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) collected from thousands of patients 18 years of age or older who have cancer or are at risk of developing cancer. In this protocol, investigators require an informed consent of patients to study their answers to survey questions that may be collected as part of their regular clinical care, permission to study their medical and related records, and permission to collect excess tissues removed at the time of planned surgery, an additional tumor sampling (needle passes) at the time of planned diagnostic biopsies, previously collected, stored tumor tissue (if available), blood, and/or other biological samples. Additional research tumor samples may be collected at the time of any diagnostic needle biopsy or endoscopic biopsy or, if available, patient tissue from a previous procedure will be obtained and utilized as needed. Clinical and related data will be collected on all patients from the time of initial entry into the study and will continue for life.
Interventions
- Procedure Collection of blood, tissue, and other biological samples.
Behavioral health assessments, including quality of life. - Other Medical Chart Review
Health data abstracted directly from patient's health records
Primary outcome measures
- Improve Standard of Cancer Care [Time frame: Time Frame: up to 20 years]
- Improve Standard of Cancer Care [Time frame: Time Frame: up to 20 years]
- Improve Standard of Cancer Care [Time frame: Time Frame: up to 20 years]
Eligibility criteria
Inclusion criteria
- 18 years of age and older.
- Diagnosed with cancer, or at risk for cancer. This includes anyone in the general population, but our primary focus will be on patients with a cancer diagnosis.
- Able to understand and sign the TCCP Informed Consent and Research Authorization form directly or through an authorized representative. The Informed Consent and Research Authorization will be available in both English and Spanish languages
Exclusion criteria
None
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Morehouse School of Medicine — Atlanta
Identifiers
NCT: NCT04804878 · 841718