CancerNCT03874065
Medical Data Collection in the Formation of Precision Oncology Registry
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
In efforts to develop an aggregation point for patient clinical data and data related to DNA sequencing in the Comprehensive Cancer Center, this registry will be developed to provide a comprehensive data store. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Medical Chart Review
- How many people
- 2,885 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 11 Jan 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population of the registry will be comprised of Wake Forest Baptist Comprehensive Cancer Center cancer patients undergoing NGS from their tumor or liquid biopsy.
Who may be able to join
- All cancer patients at Wake Forest Baptist Comprehensive Cancer Center and its satellites who are having next generation DNA sequencing ordered/performed on their tumor biopsy or surgically resected tissue and/or blood samples.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Formation of a Precision Oncology Registry
In efforts to develop an aggregation point for patient clinical data and data related to DNA sequencing in the Comprehensive Cancer Center, this registry will be developed to provide a comprehensive data store. The goal of the registry will be to collect information on the Cancer Center population undergoing next generation DNA sequencing (NGS) on their tumors or liquid biopsies.
Read the detailed description
PRIMARY OBJECTIVES:
- To capture characteristics of the patient population undergoing next generation deoxyribonucleic acid (DNA) sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.
II. To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the next generation sequencing (NGS) data.
III. To gather data regarding the patient population that may require financial assistance.
IV. To describe the patient population, in terms of demographic and clinical characteristics, who have consented to have their next generation sequencing data to be linked to their clinical records and used for future research.
- To collect overall survival for those patients with next generation sequencing data.
VI. To collect outcomes and response to the standard, experimental and/or off label treatment.
OUTLINE: Participants undergo collection of medical data to be used in the formation of a precision oncology registry. Medical data is collected as long as patients are receiving treatment for cancer.
- Conditions
- Cancer
- Being tested
- Medical Chart Review
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Collection of data from participant's medical chart
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection of Demographics, Disease and Previous Treatment
To capture characteristics of the patient population undergoing next generation DNA sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.
Measured: Approximately 2 years
Modes of Treatment for Patients
To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the NGS data.
Measured: Approximately 2 years
Populations Requiring Financial Assistance
To gather data regarding the patient population that may require financial assistance
Measured: Approximately 2 years
Demographics Collection to Assess Patient Population
To describe the patient population, in terms of demographic, who have consented to have their NGS data to be linked to their clinical records and used for future research
Measured: Approximately 2 years
Clinical Characteristics of Disease
To describe the patient population, in terms clinical characteristics, who have consented to have their NGS data to be linked to their clinical records and used for future research
Measured: Approximately 2 years
Overall Survival
To collect overall survival for those patients with NGS data
Measured: Approximately 2 years
Outcome and Response to Different Forms of Treatment
To collect outcomes and response to the standard, experimental and/or off label treatment
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start17 May 2019
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,885 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stefan Grant, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874065
- Sponsor's protocol ID
- IRB00054757
- Other IDs
- NCI-2019-01293, P30CA012197, CCCWFU 04218
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2019
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No reference to any individual participant will appear in reports, presentations, or publications that may arise from the collection of this data. The data could be used for a research study. All data provided for research will be completely deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formation of a Precision Oncology Registry
- ClinicalTrials.gov ID
- NCT03874065
- Acronym / sponsor ID
- IRB00054757
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 2,885 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 May 2019 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In efforts to develop an aggregation point for patient clinical data and data related to DNA sequencing in the Comprehensive Cancer Center, this registry will be developed to provide a comprehensive data store. The goal of the registry will be to collect information on the Cancer Center population undergoing next generation DNA sequencing (NGS) on their tumors or liquid biopsies.
Detailed description
PRIMARY OBJECTIVES:
- To capture characteristics of the patient population undergoing next generation deoxyribonucleic acid (DNA) sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.
II. To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the next generation sequencing (NGS) data.
III. To gather data regarding the patient population that may require financial assistance.
IV. To describe the patient population, in terms of demographic and clinical characteristics, who have consented to have their next generation sequencing data to be linked to their clinical records and used for future research.
- To collect overall survival for those patients with next generation sequencing data.
VI. To collect outcomes and response to the standard, experimental and/or off label treatment.
OUTLINE: Participants undergo collection of medical data to be used in the formation of a precision oncology registry. Medical data is collected as long as patients are receiving treatment for cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population of the registry will be comprised of Wake Forest Baptist Comprehensive Cancer Center cancer patients undergoing NGS from their tumor or liquid biopsy.
Key inclusion criteria (1 listed)
- All cancer patients at Wake Forest Baptist Comprehensive Cancer Center and its satellites who are having next generation DNA sequencing ordered/performed on their tumor biopsy or surgically resected tissue and/or blood samples.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Chart ReviewCollection of data from participant's medical chart | Other | – |
Primary outcome
Data Collection of Demographics, Disease and Previous Treatment
Time frame: Approximately 2 years
To capture characteristics of the patient population undergoing next generation DNA sequencing of their tumor or liquid biopsy for more efficient clinical operations by collecting data on demographics, disease, and previous treatment.
Modes of Treatment for Patients
Time frame: Approximately 2 years
To gather information on the number and type of patients that receive off label, standard, timeline or other experimental treatments based on the NGS data.
Populations Requiring Financial Assistance
Time frame: Approximately 2 years
To gather data regarding the patient population that may require financial assistance
Demographics Collection to Assess Patient Population
Time frame: Approximately 2 years
To describe the patient population, in terms of demographic, who have consented to have their NGS data to be linked to their clinical records and used for future research
Clinical Characteristics of Disease
Time frame: Approximately 2 years
To describe the patient population, in terms clinical characteristics, who have consented to have their NGS data to be linked to their clinical records and used for future research
Overall Survival
Time frame: Approximately 2 years
To collect overall survival for those patients with NGS data
Outcome and Response to Different Forms of Treatment
Time frame: Approximately 2 years
To collect outcomes and response to the standard, experimental and/or off label treatment
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No. No reference to any individual participant will appear in reports, presentations, or publications that may arise from the collection of this data. The data could be used for a research study. All data provided for research will be completely deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Grant, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection of Demographics, Disease and Previous Treatment (time frame: Approximately 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.