Recruiting

Cancer Profiling

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05049837

Conditions

Lung Cancer

Cancer of Thorax

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Specific Aim 1

Group Specific Aim 2

Group Specific Aim 3

Group Specific Aim 4

Group Specific Aim 5

Study Details

Brief summary:

In this Project, we will use therapeutic target -focused (TTF) profiling, genome-wide mRNA profiling and assessments of tumor phosphopeptides and DNA that are shed into the blood stream to define how various molecular factors alone and in combination relate to resistance to therapy, to prognosis, and to metastatic patterns at relapse. We will examine how the presence of factors that drive cell growth, antagonize apoptosis, or confer resistance in other ways may counter the effect of systemic therapies and/or promote rapid tumor recurrence. In this way, we will identify new, previously unappreciated potential therapeutic targets while also identifying which targets are most likely to increase resistance to therapy and worsen prognosis.

Conditions

Lung Cancer

Cancer of Thorax

Study ID

NCT05049837

Start date

Apr 25, 2007

Status verified date

Aug, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Eligible patients should be ones who have stage I-IIIA non-small cell lung cancer (NSCLC) and undergo surgical resection with or without neoadjuvant chemotherapy as part of standard treatment, and have a information of demographics, smoking history, preoperative clinical data, and follow -up data including adjuvant therapy, relapse, and treatment at relapse.

We will include the three major NSCLC histologic subtypes, adenocarcinoma, squamous cell carcinoma, and large cell carcinoma -

Exclusion Criteria: None

Study Design

Enrollment

7200 participants

Anticipated

Interventions and Outcome Measures

Arms

Specific Aim 1

600 cases: two normal and two tumor formalin-fixed tissue samples

Specific Aim 2

600 cases: two normal and two tumor formalin-fixed tissue samples.

Specific Aim 3

600 cases, including 150 patients who had received neoadjuvant therapy and 450 patients who had not. Two normal and two tumor formalin-fixed tissue samples.

Specific Aim 4

600 cases; including 150 patients who will receive neoadjuvant chemotherapy, 150 patients who received or will receive postoperative adjuvant chemotherapy, and 300 patients who did not receive or will not receive neoadjuvant or adjuvant chemotherapy. Two normal and two tumor formalin-fixed tissue samples

Specific Aim 5

600 cases; two normal and two tumor formalin-fixed tissue samples

Specific Aim 6

210 cases (of the 600 above), one normal and one tumor formalin-fixed histology sections obtained from formalin-fixed and paraffin- embedded tissue samples.

Interventions

Group Specific Aim 1

600 cases: two normal and two tumor formalin-fixed tissue samples

Group Specific Aim 2

600 cases: two normal and two tumor formalin-fixed tissue samples.

Group Specific Aim 3

600 cases, including 150 patients who had received neoadjuvant therapy and 450 patients who had not. Two normal and two tumor formalin-fixed tissue samples

Group Specific Aim 4

600 cases; including 150 patients who will receive neoadjuvant chemotherapy, 150 patients who received or will receive postoperative adjuvant chemotherapy, and 300 patients who did not receive or will not receive neoadjuvant or adjuvant chemotherapy. Two normal and two tumor formalin-fixed tissue samples

Group Specific Aim 5

600 cases; two normal and two tumor formalin-fixed tissue samples

Group Specific Aim 6

210 cases (of the 600 above), one normal and one tumor formalin-fixed histology sections obtained from formalin-fixed and paraffin- embedded tissue samples.

Primary outcome measure

  • To develop a therapeutic target -focused (TTF) profiling platform and to use it in vitro to identify potential therapeutic targets associated with therapeutic resistance and to develop novel approaches against these potential targets. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Luisa M Solis Soto, MD

832-794-1469lmsolis@mdanderson.org

Locations

M D Anderson Caner Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Luisa M Solis Soto, MD

832-794-1469lmsolis@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2025-08-15.