NeoplasmsNCT03269578
Sample Collection and Tracking for the Developmental Therapeutics Clinic
An observational study of Neoplasms and Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 30 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on research protocols at the Developmental Therapeutics Clinic
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
Official title: 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.
Read more
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.
...
Read the 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, sex, 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.
- Keywords
- Pharmacodynamics, Tissue Collection, Tissue Biopsies, Biospecimen, Assay Development, Natural History
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with cancer or benign tumors being treated on NCI/DTC studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining informed consent
Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials
Measured: Time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start28 Aug 2017
- Primary completion23 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alice P Chen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269578
- Sponsor's protocol ID
- 170156
- Other IDs
- 17-C-0156
- Status last verified
- 13 Oct 2026
- First submitted
- 31 Aug 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute
- ClinicalTrials.gov ID
- NCT03269578
- Acronym / sponsor ID
- 170156
- Keywords
- Pharmacodynamics, Tissue Collection, Tissue Biopsies, Biospecimen, Assay Development, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 Sep 2017 (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.
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.
...
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, sex, 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with cancer or benign tumors being treated on NCI/DTC studies |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on research protocols at the Developmental Therapeutics Clinic
Key inclusion criteria (5 listed)
- 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
- None
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.
Primary outcome
Obtaining informed consent
Time frame: Time of enrollment
Collation of research sample and treatment data from individual patients across their participation in consecutive DTC clinical trials
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Alice P Chen, M.D. principal investigator
National Cancer Institute (NCI)
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 Neoplasms and Lymphoma, run by National Cancer Institute (NCI) 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 5 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer H Zlott ((240) 760-6046, zlottjh@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining informed consent (time frame: Time of enrollment). 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 16 Oct 2026.