Breast CancerGBCPRT0008NCT01792882
Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
An observational study of Breast Cancer and Colorectal Cancer, run by Global BioClinical at 1 site in United States.
Trial summary
The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 27 Feb 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with one of the cancer indications listed below and scheduled to undergo surgical tumor resection
Who may be able to join
- Any adult age
- Any sex
- Able to provide consent for surplus tissue and/or blood donation
- Diagnosed with one of the cancer indications listed below:
- Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
- Have not yet received treatment for cancer
Who cannot join
- Not diagnosed with required cancer indication
- Not scheduled to undergo surgical resection of the tumor
- Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
- Not able to donate an adequate volume of blood to meet minimum requirements
- CANCER INDICATIONS:
- Bladder Cancer - Urothelial carcinoma - nonpapillary
Show all 35Show fewer
- Bladder Cancer - Urothelial carcinoma - papillary
- Brain Cancer - Astrocytoma
- Brain Cancer - Glioblastoma
- Brain Cancer - Medulloblastoma
- Breast Cancer - Ductal Carcinoma
- Breast Cancer - Lobular Carcinoma
- Cervical Cancer - Squamous Cell Carcinoma
- Colorectal Cancer - Adenocarcinoma
- Esophageal Cancer - Adenocarcinoma
- Gastric Cancer
- Head and Neck Cancer - Squamous Cell Carcinoma
- Hematologic Cancer - Acute Lymphocytic Leukemia (ALL)
- Hematologic Cancer - Acute Myeloid Leukemia (AML)
- Hematologic Cancer - Chronic Lymphocytic Leukemia (CLL)
- Hematologic Cancer - Diffuse Large B-cell Lymphoma
- Hematologic Cancer - Multiple Myeloma (MM)
- Hematologic Cancer - Non-Hodgkins Lymphoma (NHL)
- Kidney Cancer - Papillary Carcinoma
- Kidney Cancer - Renal cell Carcinoma
- Liver Cancer - Hepatocellular Carcinoma
- Lung Cancer - Adenocarcinoma
- Lung Cancer - Squamous Cell Cancer
- Melanoma
- Pancreatic Cancer - Ductal Adenocarcinoma
- Prostate Cancer - Adenocarcinoma
- Sarcomas
- Thyroid Cancer - Follicular Carcinoma
- Thyroid Cancer - Papillary Carcinoma
- Uterine Cancer - Endometrial Carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human cancer. The study will create a resource available to the worldwide research community that could be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. This study will be a competitive enrollment study conducted at multiple institutions.
Read the detailed description
This study will enroll subjects diagnosed with various cancers and who are scheduled to undergo surgical treatment. Prior to scheduled surgery, subjects will be asked to donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected. Subject clinical information will be collected, including basic demographic information, medical history, family history, current cancer history and treatment. After surgery, a final pathology report will be obtained for each subject's surgical specimen. In some instances and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Hematologic 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 |
|---|---|---|
| Cancer Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor genetic sequence variation
The specimens collected for this project will support genomic studies on the molecular basis of cancer. This study aims to collect specimens for a project that will systematically explore a spectrum of genomic changes involved in human cancer. Specifically the project will analyze DNA copy number changes, including large (on the order of chromosomal segments) and small (1,000 to 100,000 KB) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both tumor tissue and case-matched germline DNA. The suite of analysis platforms for collaborating laboratories will be applied to a common set of molecular analytes obtained from clinically annotated high-quality tumor specimens and case matched normal control specimens obtained form this specimen collection study. Initial measures critical to ensure specimen quality and qualification for subsequent analysis include confirmed histopathology and RNA integrity.
Measured: up to 18 months
Secondary outcomes (1)
Transcription profile
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion31 Dec 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global BioClinical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil R Mucci, Study director, Global BioClinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792882
- Sponsor's protocol ID
- GBC PRT0008
- Acronym
- GBCPRT0008
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2013
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Surplus Surgical Tumor Tissues and Pre-surgical Blood Samples
- ClinicalTrials.gov ID
- NCT01792882
- Acronym / sponsor ID
- GBCPRT0008 / GBC PRT0008
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Global BioClinicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 15 Feb 2013 (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.
The study is intended to collect specimens to support the application of genome analysis technologies, including large-scale genome sequencing. This study will ultimately provide cancer researchers with specimens that they can use to develop comprehensive catalogs of genomic information on at least 50 types of human cancer. The study will create a resource available to the worldwide research community that could be used to identify and accelerate the development of new diagnostic and prognostic markers, new targets for pharmaceutical interventions, and new cancer prevention and treatment strategies. This study will be a competitive enrollment study conducted at multiple institutions.
Detailed description
This study will enroll subjects diagnosed with various cancers and who are scheduled to undergo surgical treatment. Prior to scheduled surgery, subjects will be asked to donate a 10-20 ml blood sample. After surgery, surplus tissues (including tumor and adjacent normal tissues) not required for diagnosis will be collected. Subject clinical information will be collected, including basic demographic information, medical history, family history, current cancer history and treatment. After surgery, a final pathology report will be obtained for each subject's surgical specimen. In some instances and based on the cancer indications required, longitudinal data may also be collected at a frequency of every 6 months to once per year. Longitudinal data will include information on study subject survival and disease recurrence.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Subjects | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with one of the cancer indications listed below and scheduled to undergo surgical tumor resection
Key inclusion criteria (6 listed)
- Any adult age
- Any sex
- Able to provide consent for surplus tissue and/or blood donation
- Diagnosed with one of the cancer indications listed below:
- Scheduled to undergo surgical resection of tumor (exception for hematological cancers)
Key exclusion criteria (35 listed)
- Not diagnosed with required cancer indication
- Not scheduled to undergo surgical resection of the tumor
- Have already received cancer treatment (such as chemotherapy, radiation, surgery) for the current cancer or a previously diagnosed cancer
- Not able to donate an adequate volume of blood to meet minimum requirements
- Bladder Cancer - Urothelial carcinoma - nonpapillary
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
Tumor genetic sequence variation
Time frame: up to 18 months
The specimens collected for this project will support genomic studies on the molecular basis of cancer. This study aims to collect specimens for a project that will systematically explore a spectrum of genomic changes involved in human cancer. Specifically the project will analyze DNA copy number changes, including large (on the order of chromosomal segments) and small (1,000 to 100,000 KB) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both tumor tissue and case-matched germline DNA. The suite of analysis platforms for collaborating laboratories will be applied to a common set of molecular analytes obtained from clinically annotated high-quality tumor specimens and case matched normal control specimens obtained form this specimen collection study. Initial measures critical to ensure specimen quality and qualification for subsequent analysis include confirmed histopathology and RNA integrity.
1 secondary outcome
Transcription profile
Time frame: up to 18 months
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 28 Feb 2023.
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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.
Neil R Mucci study director
Global BioClinical
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 Breast Cancer and Colorectal Cancer, run by Global BioClinical 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 6 inclusion and 35 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: withdrawn, as of the sponsor's last update on 28 Feb 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 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.
What does the primary outcome measure?
Tumor genetic sequence variation (time frame: up to 18 months). 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 28 Feb 2023.