Penile CancerNCT05842031
Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer
An observational study of Penile Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- Quality of Life Questionnaires, Patient Educational Needs and Symptom Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- --Patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ILND and/or DSNB) and are at least 6 months post-procedure
Who cannot join
- Patient's ≤18 years of age
- Patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes
- Non-English-speaking patients For interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.
Trial locations and contacts
1 site in 1 country.
About this study
To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.
Read the detailed description
Objectives
Primary Objective:
To understand the lived experience of patients undergoing invasive inguinal lymph node procedures.
Secondary Objective:
To determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.
- Conditions
- Penile Cancer
- Being tested
- Quality of Life Questionnaires, Patient Educational Needs, Symptom Management
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnairesBehavioural
Identify what interventions may be helpful in improving quality of life.
Patient Educational NeedsBehavioural
Identify what interventions may be helpful in improving patient educational needs
Symptom ManagementBehavioural
Identify what interventions may be helpful in improving symptom management Improve symptom management
| Study group | Role | What they receive |
|---|---|---|
| Semi-structured interviews | Participants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment. Receives: Behavioral: Quality of Life Questionnaires; Behavioral: Patient Educational Needs; Behavioral: Symptom Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Regret Scale (DRS) questionnaires
Score Scale ranges (1-5)
- Strongly Agree
- Agree
- Agree nor Disagree
- Disagree
- Strongly Disagree
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start14 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Curtis Pettaway, BS, MD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842031
- Sponsor's protocol ID
- 2023-0112
- Other IDs
- NCI-2023-03504
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer
- ClinicalTrials.gov ID
- NCT05842031
- Acronym / sponsor ID
- 2023-0112
- Conditions
- Penile Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: PI requested
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.
Detailed description
Objectives
Primary Objective:
To understand the lived experience of patients undergoing invasive inguinal lymph node procedures.
Secondary Objective:
To determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semi-structured interviews | – | Behavioral: Quality of Life Questionnaires, Behavioral: Patient Educational Needs, Behavioral: Symptom ManagementParticipants with penile cancer who have undergone invasive inguinal lymph node procedure will be recruited to participate in study via telephone recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (1 listed)
- --Patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ILND and/or DSNB) and are at least 6 months post-procedure
Key exclusion criteria (3 listed)
- Patient's ≤18 years of age
- Patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes
- Non-English-speaking patients For interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life QuestionnairesIdentify what interventions may be helpful in improving quality of life. | Behavioural | Semi-structured interviews |
| Patient Educational NeedsIdentify what interventions may be helpful in improving patient educational needs | Behavioural | Semi-structured interviews |
| Symptom ManagementIdentify what interventions may be helpful in improving symptom management Improve symptom management | Behavioural | Semi-structured interviews |
Primary outcome
Decision Regret Scale (DRS) questionnaires
Time frame: through study completion; an average of 1 year
Score Scale ranges (1-5) 1. Strongly Agree 2. Agree 3. Agree nor Disagree 4. Disagree 5. Strongly Disagree
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Penile Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Not yet recruitingPhase 2
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Curtis Pettaway, BS, MD principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penile Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision Regret Scale (DRS) questionnaires (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.