Thoracic NeoplasmsTOGANCT00591981
Thoracic OncoGeriatric Assessment (TOGA) Trials
An observational study of Thoracic Neoplasms and Lung Neoplasms, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Thoracic Neoplasms, Lung Neoplasms, Esophagus Neoplasms
- What is being tested?
- TOGA Tools
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2012
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
Who may be able to join
- Patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery.
- Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates.
Who cannot join
- Institutionalized deemed not to be appropriate.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital
Madison, Wisconsin, 53792
About this study
Official title: Preoperative Oncogeriatric Assessment for Thoracic Malignancies
Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)
Read the detailed description
Our proposed TOGA wil consist of portions of the PACE and some additional screening tools, and will be applied prospectively to all patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery. Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates; other institutionalized patients will not. The preoperative TOGA will be performed by either Drs. Weigel, Maloney, LoConte or Traynor or P.A. Block. The TOGA includes parts of the PACE, involving assessment of co-morbid illness, Activities of Daily Living [ADL], Instrumental Activities of Daily Living [IADL], Geriatric Depression Screen [GDS], Brief Fatigue Inventory [BFI], Eastern Cooperative Oncology Group/Zubrod Performance Status [PS], Mini Mental State Exam (MMSE), in addition to an American Society of Anesthesiologists Score[ASA] and mini nutritional assessment (MNA), which were not done in the PACE. The TOGA should take up to 25 minutes to complete (Audisio, 2006), and will be done at only one time preoperativelOur hypothesis is that this novel, preoperative Thoracic Onco Geriatric Assessment (TOGA) will serve to predict outcomes for older patients going though thoracic oncology surgery, and thus will enhance geriatric patient care through the development of concise, validated, preoperative risk stratification.
Our hypothesis is that this abbreviated geriatric screening tool will be a better predictor for surgical and oncologic complications after surgery than performance status alone (which is currently the only measure of fitness used in routine oncology care). In addition, we predict that parts of the TOGA, specifically the instrumental activites of daily living score (IADL), mini nutritional assessment (MNA) and the brief fatigue inventory (BFI), will be the strongest predictor(s) of outcomes in our thoracic surgery population. The outcomes data we generate will also be important in quality improvement and standardization of preoperative risk assessment for elderly patients with thoracic malignancies.
- Conditions
- Thoracic Neoplasms, Lung Neoplasms, Esophagus Neoplasms, Pleural Neoplasms, Thymus Neoplasms
- Being tested
- TOGA Tools
- Keywords
- Geriatric, Thoracic, neoplasm, (Patients over 70 years of age) Geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
- Medical subject headings
- Thoracic Neoplasms, Lung Neoplasms, Esophageal Neoplasms, Pleural Neoplasms, Thymus Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOGA ToolsBehavioural
ADL's, Zubrod, IADL's, BFI, MMS, MNS, GDS
| Study group | Role | What they receive |
|---|---|---|
| Primary | All patients 70 years old and above scheduled for a thoracic oncologic surgery (typically esophageal or lung cancer) will be approached for entry into this study Receives: Behavioral: TOGA Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracey L Weigel, MD, Principal investigator, University of Wisconsin Dept of Surgery CardioThoracic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591981
- Sponsor's protocol ID
- CC06504
- Acronym
- TOGA
- Status last verified
- Jul 2015
- First submitted
- 26 Dec 2007
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oncogeriatric Assessment for Thoracic Malignancies
- ClinicalTrials.gov ID
- NCT00591981
- Acronym / sponsor ID
- TOGA / CC06504
- Conditions
- Thoracic Neoplasms, Lung Neoplasms, Esophagus Neoplasms, Pleural Neoplasms, Thymus Neoplasms
- Keywords
- Geriatric, Thoracic, neoplasm, (Patients over 70 years of age) Geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Jan 2008 (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.
Our goal is to develop a reliable, physician and patient-friendly, pre-operative Thoracic Onco-Geriatric Assessment (TOGA) to predict surgical risk in geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus, modeled upon existing CGA tools, including the Preoperative Assessment of Cancer in the Elderly (PACE)
Detailed description
Our proposed TOGA wil consist of portions of the PACE and some additional screening tools, and will be applied prospectively to all patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery. Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates; other institutionalized patients will not. The preoperative TOGA will be performed by either Drs. Weigel, Maloney, LoConte or Traynor or P.A. Block. The TOGA includes parts of the PACE, involving assessment of co-morbid illness, Activities of Daily Living [ADL], Instrumental Activities of Daily Living [IADL], Geriatric Depression Screen [GDS], Brief Fatigue Inventory [BFI], Eastern Cooperative Oncology Group/Zubrod Performance Status [PS], Mini Mental State Exam (MMSE), in addition to an American Society of Anesthesiologists Score[ASA] and mini nutritional assessment (MNA), which were not done in the PACE. The TOGA should take up to 25 minutes to complete (Audisio, 2006), and will be done at only one time preoperativelOur hypothesis is that this novel, preoperative Thoracic Onco Geriatric Assessment (TOGA) will serve to predict outcomes for older patients going though thoracic oncology surgery, and thus will enhance geriatric patient care through the development of concise, validated, preoperative risk stratification.
Our hypothesis is that this abbreviated geriatric screening tool will be a better predictor for surgical and oncologic complications after surgery than performance status alone (which is currently the only measure of fitness used in routine oncology care). In addition, we predict that parts of the TOGA, specifically the instrumental activites of daily living score (IADL), mini nutritional assessment (MNA) and the brief fatigue inventory (BFI), will be the strongest predictor(s) of outcomes in our thoracic surgery population. The outcomes data we generate will also be important in quality improvement and standardization of preoperative risk assessment for elderly patients with thoracic malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Behavioral: TOGA ToolsAll patients 70 years old and above scheduled for a thoracic oncologic surgery (typically esophageal or lung cancer) will be approached for entry into this study |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- geriatric oncology patients with thoracic neoplasms of the lung, esophagus, pleura and thymus.
Key inclusion criteria (2 listed)
- Patients 70 years old and above seen in the UWCCC for a thoracic oncology surgery.
- Residents of nursing homes and assisted living facilities will be eligible for this study if they are thought to be appropriate surgical candidates.
Key exclusion criteria (2 listed)
- Institutionalized deemed not to be appropriate.
- Prisoners
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 |
|---|---|---|
| TOGA ToolsADL's, Zubrod, IADL's, BFI, MMS, MNS, GDS | Behavioural | Primary |
Primary outcome
Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort
Time frame: 30days
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 5 Jun 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.
Tracey L Weigel, MD principal investigator
University of Wisconsin Dept of Surgery CardioThoracic Division
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 Thoracic Neoplasms and Lung Neoplasms, run by University of Wisconsin, Madison 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 2 inclusion and 2 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 5 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?
Morbidity (Cardiac, pulmonary, infectous, etc.) and Mortality in Cohort (time frame: 30days). 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 5 Jun 2023.