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

NCT ID: NCT05049837

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-25

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Lung Cancer Cancer of Thorax

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Specific Aim 1

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

Group Specific Aim 1

Intervention Type OTHER

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.

Group Specific Aim 2

Intervention Type OTHER

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.

Group Specific Aim 3

Intervention Type 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

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 4

Intervention Type 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

Specific Aim 5

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

Group Specific Aim 5

Intervention Type OTHER

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.

Group Specific Aim 6

Intervention Type 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.

Interventions

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Group Specific Aim 1

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

Intervention Type OTHER

Group Specific Aim 2

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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Group Specific Aim 5

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luisa M Solis Soto, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Caner Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Luisa M Solis Soto, MD

Role: CONTACT

832-794-1469

Facility Contacts

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Luisa M Solis Soto, MD

Role: primary

832-794-1469

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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5R01CA157450-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01CA183793

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01CA205150-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-09810

Identifier Type: OTHER

Identifier Source: secondary_id

LAB07-0233

Identifier Type: -

Identifier Source: org_study_id

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