Hematopoietic/Lymphoid CancerNCT00899808
Molecular Markers and Genetic Markers in Patients Undergoing Radiation Therapy for Cancer
An observational study of Hematopoietic/Lymphoid Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing radiation therapy for malignant disease will be eligible for these studies. Initially we will focus on specific disease sites, such as breast, prostate and lung, but ultimately we will expand this to include any disease site. Patients who met standard criteria for radiation therapy but ultimately did not receive radiation therapy will be used as a control arm if needed.
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Undergoing radiation therapy for malignant disease
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: Molecular and Genetic Markers in the Local-regional Management of Patients Undergoing Radiation Therapy
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular markers and genetic markers in patients undergoing radiation therapy for cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine local-regional control in patients undergoing radiation therapy for cancer, as a function of expression of specific molecular/genetic markers.
Secondary
- Determine complications of radiation therapy for patients undergoing radiation therapy for cancer.
OUTLINE: Previously collected tissue samples are analyzed using immunohistochemical staining and other molecular/genetic study methods to detect markers, including p53, cyclin D1, HER-2-neu, bcl-2/BAX, and EGFR. Patient charts are also reviewed with emphasis on local-regional relapse.
- Conditions
- Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, hematopoietic/lymphoid cancer
- Medical subject headings
- Hematologic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startMay 2006
- Primary completionMay 2006
Why it stopped: not "applicable clinical trial"
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic/Lymphoid CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Bruce G. Haffty, MD, Principal investigator, Rutgers Cancer Institute of New Jersey- Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899808
- Sponsor's protocol ID
- 000609
- Other IDs
- P30CA072720, CDR0000592887, CINJ-IRB-0220060141
- Status last verified
- May 2015
- First submitted
- 9 May 2009
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Genetic Markers in the Local-regional Management of Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT00899808
- Acronym / sponsor ID
- 000609
- Conditions
- Hematopoietic/Lymphoid Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
- Keywords
- unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, hematopoietic/lymphoid cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not "applicable clinical trial"
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- May 2006
- Primary completion
- May 2006 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at molecular markers and genetic markers in patients undergoing radiation therapy for cancer.
Detailed description
OBJECTIVES:
Primary
- Determine local-regional control in patients undergoing radiation therapy for cancer, as a function of expression of specific molecular/genetic markers.
Secondary
- Determine complications of radiation therapy for patients undergoing radiation therapy for cancer.
OUTLINE: Previously collected tissue samples are analyzed using immunohistochemical staining and other molecular/genetic study methods to detect markers, including p53, cyclin D1, HER-2-neu, bcl-2/BAX, and EGFR. Patient charts are also reviewed with emphasis on local-regional relapse.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing radiation therapy for malignant disease will be eligible for these studies. Initially we will focus on specific disease sites, such as breast, prostate and lung, but ultimately we will expand this to include any disease site. Patients who met standard criteria for radiation therapy but ultimately did not receive radiation therapy will be used as a control arm if needed.
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
Related trials for Hematopoietic/Lymphoid Cancer
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
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.
Bruce G. Haffty, MD principal investigator
Rutgers Cancer Institute of New Jersey- Robert Wood Johnson Medical School
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 Hematopoietic/Lymphoid Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 May 2015. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 29 May 2015.