NCT03269578

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. ...

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2017May 2027

Study Start

First participant enrolled

August 28, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2027

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

April 24, 2026

Status Verified

June 27, 2025

Enrollment Period

9.7 years

First QC Date

August 31, 2017

Last Update Submit

April 23, 2026

Conditions

Keywords

PharmacodynamicsTissue CollectionTissue BiopsiesBiospecimenAssay DevelopmentNatural History

Outcome Measures

Primary Outcomes (1)

  • Obtaining informed consent

    Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials

    Time of enrollment

Study Arms (1)

1

Patients with cancer or benign tumors being treated on NCI/DTC studies

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients on research protocols at the Developmental Therapeutics Clinic

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

NeoplasmsLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Alice P Chen, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer H Zlott

CONTACT

Alice P Chen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

August 28, 2017

Primary Completion (Estimated)

May 23, 2027

Study Completion (Estimated)

May 30, 2027

Last Updated

April 24, 2026

Record last verified: 2025-06-27

Locations