Sample Collection and Tracking for the Developmental Therapeutics Clinic

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

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.

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Study Overview

• Status: Recruiting
• Conditions: 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 or benign tumors 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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Jennifer H Zlott; Phone Number: (240) 760-6046; Email: zlottjh@mail.nih.gov
• Study Contact Backup: Name: Alice P Chen, M.D.; Phone Number: (240) 781-3320; Email: chenali@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office; Phone Number: 888-624-1937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients on research protocols at the Developmental Therapeutics Clinic

Description

• INCLUSION CRITERIA:
• Patients who are being evaluated and/or treated for cancer or benign tuumors 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

ECLUSION CRITERIA:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Patients with cancer or benign tumors being treated on NCI/DTC studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obtaining informed consent	Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials	Time of enrollment

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alice P Chen, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Estimated): May 23, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 13, 2023

More Information

Terms related to this study

• Keywords: Natural History; Pharmacodynamics; Assay Development; Biospecimen; Tissue Collection; Tissue Biopsies
• Other Study ID Numbers: 170156; 17-C-0156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No