Comparative-effectiveness of pretreatment lung cancer nodal staging

Ended Project Grant Awarded Last action

Award ID
R01CA258352
Recipient
Awarding agency
Obligated
$13,090,922

Award facts

Assistance listing
93.393 Cancer Cause and Prevention Research
Completion date
Originally
Funding
  • $11,873,613.00 Federal
  • $1,217,309.00 Non-federal
Place of performance
Seattle, WA 98195, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Our goal is to reduce diagnostic and treatment errors, improve survival, and increase the value of care for lung cancer patients by improving our ability to select patients who benefit from a pretreatment lymph node biopsy. Accurately determining whether cancer has spread to lymph nodes and the extent of spread (a process called nodal staging) is critical for appropriate treatment selection. Understaging can lead to omission of chemotherapy or unnecessary surgery. Overstaging can lead to unnecessary chemotherapy and omission of surgery. Diagnostic and treatment errors negatively impact survival. These errors commonly occur when using imaging alone for nodal staging. A biopsy can reduce the chances of error, but IT can also result in rare, life- threatening adverse events. Each biopsy costs ~$5,000. Practice guidelines recommend selectively performing a biopsy when imaging findings suggest nodal disease. However, national biopsy rates are less than half of what they should be. Moreover, there is 25-fold facility-level variability not explained by access to care, case- mix, or clinician or facility characteristics. These findings, along with the low levels of evidence underlying guideline recommendations, suggest true clinical and scientific uncertainty over the indications for lymph node biopsy. We conducted a pilot study to better understand how well guideline recommendations select patients for biopsy and learned that guideline-concordant nodal staging selects all patients with true nodal disease for biopsy and two-thirds of patients without true nodal disease for biopsy. Additionally, we developed and validated an alternative risk-based nodal staging strategy that uses a prediction model to stratify and select patients for lymph node biopsy. Preliminary data show that IT identifies nearly all patients with true nodal disease for biopsy but selects fewer patients without nodal true nodal disease for biopsy. However, the relationship between selection strategies for lymph node biopsy and patient outcomes remains unknown. We hypothesize that guideline-concordant nodal staging is associated with higher 5-year survival rates compared with guideline-discordant nodal staging (aim i) and that risk-based nodal staging is equivalent to guideline- concordant nodal staging in terms of survival but superior in terms of lower biopsy-related adverse events and healthcare expenditures (aim II). Testing these hypotheses will require ~4,000 patients; therefore, a trial is not feasible at this time. We will create a novel cohort of lung cancer patients using the cancer research network infrastructure to conduct aim i using an observational, comparative-effectiveness study design with advanced regression techniques and machine learning to minimize confounding. Additionally, we will use patient-level data from this cohort as model inputs in a comparative-effectiveness simulation model that we will develop to conduct aim II. Findings from this study will lead to: 1) developing and testing implementation strategies designed to increase guideline-concordant nodal staging, 2) alternative guideline recommendations for nodal staging, and/or 3) justifying trials comparing outcomes between different nodal staging strategies.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $27,078 $0
Amendment $27,078 $0
Amendment $243,703 $0
Amendment $243,703 $0
Amendment $243,703 $0
Amendment $60,136 $0
Amendment $60,136 $0
Amendment $0 $0
Amendment $0 $0
Amendment $541,223 $0
Amendment $541,223 $0
Amendment $541,223 $0
Amendment $541,223 $0
Amendment $541,223 $0
Amendment $541,223 $0
Amendment $29,986 $0
Amendment $29,986 $0
Amendment $29,986 $0
Amendment $29,986 $0
Amendment $539,713 $0
Amendment $539,713 $0
Amendment $539,713 $0
Amendment $539,713 $0
Amendment $539,713 $0
Amendment $49,032 $0
Amendment $49,032 $0
Amendment $49,032 $0
Amendment $551,603 $0
Amendment $551,603 $551,603
Amendment $551,603 $0
Amendment $551,603 $0
Amendment $551,603 $0
Amendment $665,706 $0
Amendment $665,706 $665,706
Original award $665,706 $0
Show all 36

Subawards

Subrecipient Amount Awarded
Marshfield Clinic Comparative-Effectiveness of Pretreatment Lung Cancer Nodal Staging. -$21,000
Marshfield Clinic $24,760
The Medical University Of South Carolina $10,796
Kaiser Foundation Hospitals $12,435
Kaiser Foundation Hospitals $40,416
Marshfield Clinic ComparativeEffectiveness of Pretreatment Lung Cancer Nodal Staging. $60,678
Kaiser Foundation Hospitals Comparative-Effectiveness of Pretreatment Lung Cancer Nodal Staging. $27,693
The Medical University Of South Carolina $24,613
Kaiser Foundation Hospitals $87,344
The Medical University Of South Carolina $2,424
Kaiser Foundation Hospitals $12,980
Marshfield Clinic $92,648
Kaiser Foundation Hospitals $2,770
Show all 13

Quick answers

Who received award R01CA258352?

R01CA258352 was awarded to University Of Washington by National Cancer Institute (National Institutes of Health) on January 17, 2022.

How much is award R01CA258352 worth?

$13,090,922 has been obligated on R01CA258352: $11,873,613 in federal funding and $1,217,309 in non-federal funding.

On GovTribe

See this award's full record

  • Every transaction and subaward
  • The recipient's other awards and teaming partners
  • Similar grant awards
  • Ask GovTribe AI about this award
Try for free Login