MelanomaNCT00001503
Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease
An observational study of Melanoma and Ovarian Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Melanoma, Ovarian Cancer, Prostate Cancer
- How many people
- 1,031 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 1996to 15 Jun 2023
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of any age who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.
- ELIGIBILITY CRITERIA:
Patients of any age who were previously enrolled on a CCR protocol.
Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.
CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.
Patient or Legally Authorized Representative (LAR)/guardian is able to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols
This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.
Read the detailed description
Background:
- Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
- Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.
Objectives:
-To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.
Eligibility:
-Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.
Design:
- The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
- Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
- Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.
- Conditions
- Melanoma, Ovarian Cancer, Prostate Cancer, Breast Cancer, Lymphoma
- Keywords
- Cancer, Late-effects, Survival, Follow-Up, Natural History
- Medical subject headings
- Melanoma, Ovarian Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Lymphoma, Neoplasms
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/All Patients | Patients who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol
Provision of a mechanism to follow selected CCR patients when their protocols have been terminated.
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start19 Sep 1996
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Prospective
- Enrolment
- 1,031 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001503
- Sponsor's protocol ID
- 960071
- Other IDs
- 96-C-0071
- Status last verified
- Jun 2023
- First submitted
- 3 Nov 1999
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols
- ClinicalTrials.gov ID
- NCT00001503
- Acronym / sponsor ID
- 960071
- Conditions
- Melanoma, Ovarian Cancer, Prostate Cancer, Breast Cancer, Lymphoma
- Keywords
- Cancer, Late-effects, Survival, Follow-Up, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,031 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Sep 1996 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 4 Nov 1999 (estimated)
- 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.
This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.
Detailed description
Background:
- Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
- Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.
Objectives:
-To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.
Eligibility:
-Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.
Design:
- The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
- Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
- Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/All Patients | – | –Patients who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.
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
To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol
Time frame: 30 years
Provision of a mechanism to follow selected CCR patients when their protocols have been terminated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
James L Gulley, 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 Melanoma and Ovarian Cancer, 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?
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: finished, as of the sponsor's last update on 18 Jun 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol (time frame: 30 years). 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 18 Jun 2023.