Sample Collection and Tracking for the Developmental Therapeutics Clinic

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT03269578

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

43.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

People who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time.

Objective:

To enter people into a master protocol to connect research sample and treatment data across DTC studies.

Eligibility:

People ages 18 and older who are being evaluated or treated for cancer in the DTC

Design:

Participants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies.

Participants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment.

Participants will provide no new samples.

...

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Lymphoma

Detailed Description

Background:

Research samples and data collected on a treatment-intent protocol are discrete items associated with that protocol up until the patient comes off study, usually due to disease progression. These data are not stored in the patient s medical records, but are essential to understand tumor response to different drugs over time. Patients in the Developmental Therapeutics Clinic (DTC) often start other clinical trials; this protocol provides a mechanism to connect research data about that patient from one trial to the next as long as the patient remains eligible and has given his or her informed consent. No new analysis will be performed under this protocol.

There is research interest in collecting pre- and post-dose research biopsies and other samples such as circulating tumor cells to measure dynamic drug-specific target effects (e.g., changes in epithelial-mesenchymal transition, DNA damage response, or immunotherapeutic cell infiltration), and then to evaluate molecular changes before and during disease progression to understand why the tumors initially respond but then became resistant to treatment.

To accomplish this, we will connect research results from consecutive trials with limited patient information (age, gender, disease, prior therapies, protocol number/drug regimen, response, and duration of treatment).

Each patient who consents to participate in this non-treatment, longitudinal sample protocol agrees to allow his or her Medical Record Number (MRN) to be used to track participation on DTC clinical trials.

Objectives:

Patients will be entered onto this "master" longitudinal protocol to connect research sample and treatment data across consecutive DTC clinical trials.

Biopsy samples collected at time of disease progression on one research trial will be evaluated for use as the baseline sample for the next research trial, potentially obviating the need for additional biopsies.

Eligibility:

Adult patients who are being evaluated for and/or treated for cancer at the DTC.

Design:

No samples will be collected under this longitudinal protocol, no treatment decisions will be made based on data collected, and no new analysis will be performed.

Specimens for research purposes, as outlined in this protocol, will be those obtained from tests and procedures that are done as required by the primary research protocols that a given patient is enrolled in. Tissue collected under DTC tissue procurement protocol 06-C-0213 will not be used or tracked.

Sample location and use will be managed in the Repository at the Frederick National Laboratory for Cancer Research using LabMatrix software.

Patients may remain on this longitudinal protocol for the duration of their consent.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute

Actual Study Start Date :

Aug 28, 2017

Anticipated Primary Completion Date :

May 23, 2023

Anticipated Study Completion Date :

May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with advanced, refractory cancers being treated on NCI/DTC studies

Outcome Measures

Primary Outcome Measures

Obtaining informed consent from participants to track their clinical research data across different Developmental Therapeutics Clinic clinical trials [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
Patients who are being evaluated and/or treated for cancer in the Developmental Therapeutics Clinic at the NIH Clinical Center
Ability to understand and willingness to sign a written informed consent document indicating their willingness to have data from their tissue or biologic fluid research specimens and limited medial information used for research as outlined in this protocol and to allow protocol staff access to the CRIS database and their Medical Records Number (MRN).
Age greater than or equal to 18 years