Houston, TXNCT03819296Now EnrollingIRB Ready

Clinical Stage 0 Cutaneous Melanoma AJCC v8 Clinical Trial in Houston, TX

Access cutting-edge clinical stage 0 cutaneous melanoma ajcc v8 treatment through this clinical trial at a research site in Houston. Study-provided care at no cost to qualified participants.

Sponsored by M.D. Anderson Cancer Center

Quick Self-Assessment

See if you qualify for this Houston location

Preparing your pre-screening questions…

Expert Care in Houston

Access clinical stage 0 cutaneous melanoma ajcc v8 specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related clinical stage 0 cutaneous melanoma ajcc v8 treatment provided free

Apply for This Houston Location

Check if you qualify for this clinical stage 0 cutaneous melanoma ajcc v8 clinical trial in Houston, TX

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Houston

    Convenient for TX residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Houston site if eligible
  4. 4Begin participation

About This Clinical Stage 0 Cutaneous Melanoma AJCC v8 Study in Houston

This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).
Diagnosis of any cancer type (Projects 2 and 3)
Treatment with any ICPI agent
Ability to understand and willingness to sign an informed consent form and rate surveys
Life expectancy \> 4 months (Project 3)
ICPI-related diarrhea and/or colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)
Patients with no organ toxicity as the control group (project 1)
ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)
ICPI-related colitis and/or diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)
ICPI-related colitis and/or diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3): (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab, (ii) contraindication for immunosuppressive treatment, (iii) recurrence after successful initial treatment, (iv) recurrent symptoms once steroid is tapered down/off or diarrhea/colitis symptoms are steroid dependent, or (v) patients with a history of refractory ICPI-related colitis and/or diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT
No concern for active concomitant GI infection for the ICPI diarrhea/colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)
Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment (project 3)

Exclusion Criteria

Age younger than 18 years
History of inflammatory bowel disease, and/or radiation enteritis or colitis with active disease status at the time of study treatment initiation
Pregnant and breastfeeding women
Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \> 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment
Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)
Patients with active bacterial or fungal infection (Project 3)
Donors at risk for monkeypox infection and/ or exposure as determined by a questionnaire (Project 3) Withdrawal Criteria
Patients may withdraw from the trial at any time
Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis
In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT03819296) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Clinical Stage 0 Cutaneous Melanoma AJCC v8 Treatment Options in Houston, TX

If you're searching for clinical stage 0 cutaneous melanoma ajcc v8 treatment options in Houston, TX, this clinical trial (NCT03819296) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced clinical stage 0 cutaneous melanoma ajcc v8 specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all clinical stage 0 cutaneous melanoma ajcc v8 clinical trials near you to find additional studies recruiting in your area.

More Melanoma Trials in Houston, TX

See all melanoma clinical trials recruiting in Houston — not just this study.

Browse Melanoma Trials in Houston →

Browse More Trials by Condition

Melanoma TrialsInterstitial Cystitis TrialsMyalgic Encephalomyelitis TrialsAll Conditions →

Ready to Join in Houston?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Houston, TX