Recruiting

Lung Cancer Staging

Sponsor:

Brigham and Women's Hospital

Code:

NCT06252129

Conditions

Lung Cancer

Lymph Node Metastasis

Pathologic Processes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Subjects undergoing a lung specimen lymph node dissection

Control group

Study Details

Brief summary:

Lung cancer patients undergoing upfront surgery, highly benefit from a systematic lymph node dissection in the mediastinum and in the surgical specimens. The latter is performed by the pathologist. Developing a standardized technique to dissect the lobectomy specimen has the potential of maximizing the retrieval of all N1 stations lymph nodes. The investigators believe that the adoption of such technique will improve lung cancer staging and identify a higher number of patients that qualify for adjuvant therapies.

Conditions

Lung Cancer

Lymph Node Metastasis

Pathologic Processes

Study ID

NCT06252129

Start date

Jul 26, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subjects with a lung nodule or mass who are eligible to undergo a lobectomy.
2. Subject without any metastasis present.
3. Subjects who have peripheral lung nodule location
4. Subjects must be 18 years of age or older.

Exclusion Criteria:

1. Subjects who received preoperative chemotherapy or radiotherapy.
2. Subjects who have a lung nodule located in a central location. Central tumors are defined by those infiltrating the lobar airway.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 1. Interventional group

subjects who are being consented to this study and undergoing lymph node dissection as outlined in this protocol

no intervention: Concurrent non-interventional group

other: Retrospective cohort from 2021-2020

Interventions

Subjects undergoing a lung specimen lymph node dissection

A lobectomy specimen's resection will undergo systematic lymph node dissection either by the patient's treating thoracic surgeon and/or by a member of the pathology team.

The protocol for a standardized lymph node dissection consists of a series of blunt peribronchial dissections starting from the hilum to the periphery, with particular attention to points of airway bifurcation where intrapulmonary lymph nodes aggregate. By emphasizing the intrapulmonary lymph node map and a standardized dissection, the team will remove more lymph nodes from the lobectomy specimen, resulting in an accurate N staging.

Control group

Control group

Primary outcome measure

  • Number of lymph nodes sampled [ Time Frame: 2 weeks ]
  • Nodal upstage rate [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Paula Ugalde Figueroa, M.D.

(617) 732-7696pugaldefigueroa@bwh.harvard.edu

Locations

Brigham and Womens Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Paula Ugalde Figueroa THORACIC SURGEON, MD

617-794-6491pugaldefigueroa@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • NSCLC
  • Lymph node dissection
  • Lung cancer staging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-03-05.