ClinicalTrials.gg
CompletedNCT03413449Updated Nov 14, 2024

A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

An observational study in Thoracic, Thoracic Neoplasm and Lung Cancer, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.

Primary conditionLung NeoplasmsRegistry: Thoracic NeoplasmsReclassifiedWhy we changed it
Registry
Thoracic Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lung Neoplasms
Why
  1. The study's listed conditions name Lung Neoplasms, a narrower term within Thoracic Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
360
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,459 studies in Lung Neoplasms with a site in United States — 423 open to participants now, 644 under way, 53 of them phase 3. Lung Neoplasms · United States.

Enrollment
138th of 442
360 · median 123
Started
2018
with 97 others
Observational
443 of 2,459
95 open now
Registered
1,483rd of 2,459
by date

Among the 2,459 studies in Lung Neoplasms with a site in United States, this one is the 138th largest by enrollment of the 442 observational ones that give a count, is one of 98 that started in 2018, is one of 443 observational ones, and was the 1,483rd registered.

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

Browse Lung Neoplasms studies →

Open to participants now

423 of the 2,459 studies in Lung Neoplasms with a site in United States are open now. Recruiting first, the newest first:

418 more — sign in →

All 423 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 996 Lung Neoplasms studies recruiting now, 683 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,459 studies in Lung Neoplasms with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

Read the detailed description

Frailty is a widely accepted but poorly defined physical condition that has been shown to be an independent predictor of surgical morbidity and direct discharge to skilled nursing facility (SNF). Attempts have been made to study frailty in surgical patients by employing models designed for the general population. Despite the attempts of studying frailty in general surgery patients, no study has designed a model comprised of objective metrics for general thoracic surgery patients.

The purpose of this study is to better understand frailty in the context of thoracic surgery patients and to develop an objective model of this nebulous variable. It is hoped that standard, simple, functional and laboratory data can be used to construct the model with the goal being to determine the impact of frailty on outcome for patients undergoing esophagectomy, lobectomy, or pneumonectomy. If a preoperative frailty index can be developed and demonstrated to predict outcome, this scoring system may allow care teams to predict post-operative complications, ICU and hospital recidivism, and early mortality, and possibly allow for much earlier preparation for unfavorable outcomes.

03

Conditions studied

  • Thoracic
  • Thoracic Neoplasm
  • Lung Cancer
  • Esophageal Cancer
  • Surgery--Complications
  • Surgery
  • Sarcopenia
  • Malnutrition
  • Frail Elderly Syndrome
04

In context

Lung Neoplasms Reclassified

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's enrollment of 360 is above the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Compared within Lung Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thoracic Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are diagnosed with esophageal or lung cancer and are referred for surgery are included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients >18 years old who are undergoing pneumonectomy, lobectomy or esophagectomy with a cancer diagnosis over a 1-year enrollment.

Exclusion criteria

Exclusion Criteria:

  • Patients who are unable to sign a consent.
06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
360 participants (actual)
Patient registry
No

Groups and cohorts

  • Resections

    Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer

    Diagnostic Test: Frailty model

Interventions

  • Diagnostic testFrailty model

    1. Grip strength 2. 30 second chair sit stand test 3. Psoas muscle area 4. Six minute walk

07

What researchers measure

Primary outcomes

  1. Morbidity

    Number of STS defined complications (chest tube airleak, atelectasis, pleural effusion requiring drain, pneumonia, ARDS, respiratory failure, bronchopleural fistula, PE, pneumothorax, chylothorax, ventilator \> 48 hours, tracheostomy, tracheobronchial injury, ileus, anastomotic leak, GI dilation, conduit necrosis requiring surgery, delayed conduit emptying, C. diff, delirium) will be combined to report the number of morbidity events

    Time frame: Assessed at discharge and will be reported through study completion, an average of 1 year

  2. Discharge status

    Discharge destination

    Time frame: Assessed at discharge and will be reported through study completion, an average of 1 year

Secondary outcomes

  1. Length of stay

    Time spent in the hospital during perioperative stay

    Time frame: Assessed from date of surgery until the date of discharge and will be reported through study completion, an average of 1 year

  2. 30 day readmission

    If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission

    Time frame: Assessed from date of discharge to thirty days after discharge and will be reported through study completion, an average of 1 year

08

Study locations

1 site
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jun 2021, 41 months.

Of 591 non-industry observational studies under Lung Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 162. This study's 41 months is below that.

Counting every sponsor, half of 681 studies reached it within 57 months; a quarter within 25 and three quarters within 135.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2018
First posted
Jan 29, 2018
StartActual
Jan 8, 2018
Primary completionActual
Jun 22, 2021
CompletionActual
Nov 8, 2024
Last update
Nov 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03413449
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Jan 8, 2018
Primary completion
Jun 22, 2021
Completion
Nov 8, 2024
Last update
Nov 14, 2024

Study contacts

Sudish Murthy, MD, PhD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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