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NCT Number: NCT05049837

PROSPECT - Profiling of Resistance Patterns & Oncogenic Signaling Pathways in Evaluation of Cancers of the Thorax and Therapeutic Target Identification

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.

Recruiting

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Key information

Conditions

Lung Cancer Cancer of Thorax Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Caner Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Luisa M Solis Soto, MD

CONTACT

[email protected]

832-794-1469

About this study

Objectives:

  • 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.
  • To use tumor tissue TTF profiling along with genome wide mRNA profiling, serum phosphopeptide profiling and plasma DNA profiling to identify and evaluate molecular targets and pathways that contribute to therapeutic sensitivity or resistance, prognosis, and recurrence patterns in patients with operable non-small cell lung carcinoma (NSCLC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Specific Aim 1

Other

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

Group Specific Aim 2

Other

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

Group Specific Aim 3

Other

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

Other

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

Other

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

Group Specific Aim 6

Other

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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Luisa M Solis Soto, MD

CONTACT

[email protected]

832-794-1469

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • United States Department of Defense

Registry information

Important dates

Study start
2007
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2021
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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