Carcinoma, Non-Small Cell LungNCT00263731
Metabolomic Analysis of Lung Cancer
An observational study of Carcinoma, Non-Small Cell Lung and Carcinoma, Small Cell Lung, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the metabolic properties of lung cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung
- What is being tested?
- 13-C-glucose
- Type of treatment
- Injection or infusion
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to 24 Sep 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Group 1 (experimental group): 250 lung cancer patients undergoing surgery, with 13-C-glucose infusion); * Group 2 (control group): 250 lung cancer patients undergoing surgery, without 13-C-glucose infusion); and * Group 3 (healthy subjects): 250 subjects to provide 1 blood sample and 1 urine sample.
Who may be able to join
- patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. Occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for NSCLC, as warranted by the particulars of the case.
- patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor
- at least 30 years of age
- preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
Who cannot join
- history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose)
- known hepatitis C or HIV (AIDS)
- Healthy Subjects (Group 3)
- prior history of diagnosed lung cancer
- known hepatitis C or HIV (AIDS)
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center
The purpose of this study is to learn more about the metabolic properties of lung cancer cells.
Read the detailed description
It has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. This process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. Recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. The objective of the study is to characterize the metabolism of glucose by lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.
- Being tested
- 13-C-glucose
- Keywords
- lung cancer, non-small cell lung cancer, small cell lung cancer, cancer metabolism
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13-C-glucoseOther
10 grams of 13-C-glucose intravenously, as a 30-minute "piggyback" infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Experimental Group) | 250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery Receives: Other: 13-C-glucose | |
| Group 2 (Control Group) | 250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery | |
| Group 3 (Healthy Subjects) | 250 healthy subjects (must be at least 30 years of age and have no prior history of diagnosed lung cancer) will provide 1 blood sample and 1 urine sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic profiles of cancerous vs. healthy lung tissue
Measured: after 13-C-glucose infusion
Secondary outcomes (5)
glycolytic metabolism in plasma
Measured: before and after 13-C-glucose infusion
metabolic markers in urine
Measured: collected during surgery
metabolic markers in serum
Measured: before and after 13-C-glucose infusion
metabolic markers in bronchoalveolar fluid
Measured: during diagnostic bronchoscopy or during surgery
metabolic markers in expired breath
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startDec 2005
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Donald Miller, University of Louisville
- Investigators
- Donald M Miller, MD, PhD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263731
- Sponsor's protocol ID
- 523.05
- Other IDs
- BCC-LUN-05-002
- Status last verified
- May 2022
- First submitted
- 7 Dec 2005
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Metabolomic Analysis of Primary Lung Cancer: A Translational Clinical Trial of the Brown Cancer Center
- ClinicalTrials.gov ID
- NCT00263731
- Acronym / sponsor ID
- 523.05
- Keywords
- lung cancer, non-small cell lung cancer, small cell lung cancer, cancer metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Dec 2005
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 9 Dec 2005 (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 purpose of this study is to learn more about the metabolic properties of lung cancer cells.
Detailed description
It has long been known that cancer cells absorb and break down substances in the body differently than healthy, non-cancer cells. This process of absorbing and breaking down substances is known as metabolism and is increased in cancer cells. Recent research suggests that this increased metabolic activity makes it easier for cancer cells to multiply. The objective of the study is to characterize the metabolism of glucose by lung tumors by serum metabolite analysis, using a variant of glucose (sugar) which makes up 1% of glucose in nature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Experimental Group) | – | Other: 13-C-glucose250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will receive 13-C-glucose prior to surgery |
| Group 2 (Control Group) | – | –250 subjects with suspected or confirmed lung cancer undergoing surgical resection, will not receive 13-C-glucose prior to surgery |
| Group 3 (Healthy Subjects) | – | –250 healthy subjects (must be at least 30 years of age and have no prior history of diagnosed lung cancer) will provide 1 blood sample and 1 urine sample. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Group 1 (experimental group): 250 lung cancer patients undergoing surgery, with 13-C-glucose infusion); * Group 2 (control group): 250 lung cancer patients undergoing surgery, without 13-C-glucose infusion); and * Group 3 (healthy subjects): 250 subjects to provide 1 blood sample and 1 urine sample.
Key inclusion criteria (4 listed)
- patients with suspected, clinically diagnosed, or histologically diagnosed lung cancer. Occasionally, other cancers (including metastatic cancers to the lung) may be resected for the study as negative controls for NSCLC, as warranted by the particulars of the case.
- patients must have general medical conditions to allow them to undergo surgical resection of their primary tumor
- at least 30 years of age
- preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
Key exclusion criteria (5 listed)
- history of diabetes for the experimental group (surgery + glucose); patients with a history of diabetes are allowed in the control group (surgery/no glucose)
- known hepatitis C or HIV (AIDS)
- Healthy Subjects (Group 3)
- prior history of diagnosed lung cancer
- known hepatitis C or HIV (AIDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13-C-glucose10 grams of 13-C-glucose intravenously, as a 30-minute "piggyback" infusion, 2 to 6 hours prior to scheduled surgical resection of primary lung cancer. | Other | Group 1 (Experimental Group) |
Primary outcome
metabolic profiles of cancerous vs. healthy lung tissue
Time frame: after 13-C-glucose infusion
5 secondary outcomes
glycolytic metabolism in plasma
Time frame: before and after 13-C-glucose infusion
metabolic markers in urine
Time frame: collected during surgery
metabolic markers in serum
Time frame: before and after 13-C-glucose infusion
metabolic markers in bronchoalveolar fluid
Time frame: during diagnostic bronchoscopy or during surgery
metabolic markers in expired breath
Time frame: during surgery
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 9 May 2022.
- James Graham Brown Cancer CenterLink 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. This study is not recruiting at the moment.
Donald M Miller, MD, PhD principal investigator
James Graham Brown Cancer Center
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 Carcinoma, Non-Small Cell Lung and Carcinoma, Small Cell Lung, run by University of Louisville 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 May 2022. 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?
metabolic profiles of cancerous vs. healthy lung tissue (time frame: after 13-C-glucose infusion). 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 9 May 2022.