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

February 12, 2024 updated by: M.D. Anderson Cancer Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Objectives:

  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.
  2. 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).

Study Type

Observational

Enrollment (Estimated)

7200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

M D Anderson Cancer Center (Lung Cancer Patients)

Patients should be ones who have stage I-IIIA non-small cell lung cancer (NSCLC)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Specific Aim 1
600 cases: two normal and two tumor formalin-fixed tissue samples
Other: Group 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.
Other: Group 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.
Other: 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
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
Other: 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
Specific Aim 5
600 cases; two normal and two tumor formalin-fixed tissue samples
Other: Group 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

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

Investigators

  • Principal Investigator: Ignacia Wistuba, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2007

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 20, 2021

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LAB07-0233
  • 5R01CA157450-05 (U.S. NIH Grant/Contract)
  • 5R01CA183793 (U.S. NIH Grant/Contract)
  • 1R01CA205150-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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